Acetaminophen And Codeine Phosphate (Acetaminophen And Codeine Phosphate)

Trade Name : Acetaminophen and Codeine Phosphate

NCS HealthCare of KY, Inc dba Vangard Labs

TABLET

Strength 30030 mg/1mg/1

ACETAMINOPHEN; CODEINE PHOSPHATE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Acetaminophen And Codeine Phosphate (Acetaminophen And Codeine Phosphate) which is also known as Acetaminophen and Codeine Phosphate and Manufactured by NCS HealthCare of KY, Inc dba Vangard Labs. It is available in strength of 300; 30 mg/1; mg/1 per ml. Read more

Acetaminophen And Codeine Phosphate (Acetaminophen And Codeine Phosphate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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WARNING:u00a0ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE; HEPATOTOXICITY; CYTOCHROME P450 2D6 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTSn- Addiction, Abuse, and Misusen- Acetaminophen and Codeine Phosphate Tablets expose patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing Acetaminophen and Codeine Phosphate Tablets, and monitor all patients regularly for the development of these behaviors and conditions [see ].u00a0n- Arrayn- Serious, life-threatening, or fatal respiratory depression may occur with use of acetaminophen and codeine phosphate tablets. Monitor for respiratory depression, especially during initiation of acetaminophen and codeine phosphate tablets or following a dose increase [see ].n- Arrayn- Accidental ingestion of even one dose of acetaminophen and codeine phosphate tablets, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate tablets [see ].n- Arrayn- Prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see ].
Death Related to Ultra-Rapid Metabolism of Codeine to Morphinen- Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism [see n- , n- ; n- ].n- Arrayn- Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see .
Interactions with Drugs Affecting Cytochrome P450 Isoenzymesn- The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with Acetaminophen and Codeine Phosphate Tablets requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.
Cytochrome P450 3A4 Interactionn- The concomitant use of Acetaminophen and Codeine Phosphate Tablets with all cytochrome P450 3A4 inhibitors or discontinuation of a cytochrome P450 3A4 inducer may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome P450 2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.
The concomitant use of Acetaminophen and Codeine Phosphate Tablets with all cytochrome P450 3A4 inducers or discontinuation of a cytochrome P450 3A4 inhibitor may result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels. This may be associated with a decrease in efficacy, and in some patients, may result in signs and symptoms of opioid withdrawal.
Follow patients receiving Acetaminophen and Codeine Phosphate Tablets and any CYP3A4 inhibitor or inducer for signs and symptoms that may reflect opioid toxicity and opioid withdrawal when Acetaminophen and Codeine Phosphate Tablets is used in conjunction with inhibitors and inducers of CYP3A4 [see Warnings, Precautions, Drug Interactions].
Cytochrome P450 2D6 Interactionn- The concomitant use of Acetaminophen and Codeine Phosphate Tablets with all cytochrome P450 2D6 inhibitors may result in an increase in codeine plasma concentrations and a decrease in the plasma concentration of the active metabolite, morphine, which could result in an analgesic efficacy reduction or symptoms of opioid withdrawal.
The discontinuation of a cytochrome P450 2D6 inhibitor may result in a decrease in codeine plasma concentrations and an increase in the plasma concentration of the active metabolite, morphine, which could which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.
Follow patients receiving Acetaminophen and Codeine Phosphate Tablets and any CYP2D6 inhibitor for signs and symptoms that may reflect opioid toxicity and opioid withdrawal when Acetaminophen and Codeine Phosphate Tablets are used in conjunction with inhibitors of CYP2D6 [see n- ,n- , n- ].
Risks from concomitant use with Benzodiazepines or other CNS Depressantsn- Concomitant use of opiods with benzodiazepines or other central nervous system (CNS) depressants including alcohol, may result in profound sedation, respiratory depression, coma, and death. [see ,; n- u2022 Reserve concomitant prescribing of acetaminophen and codeine phosphate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.n- u2022 Limit dosages and durations to the minimum required.n- u2022 Follow patients for signs and symptoms of respiratory depression and sedation.

Acetaminophen and codeine phosphate tablets, USPu00a0are for oral administration.n Acetaminophen, 4u2019-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
Codeine phosphate, 7,8-didehydro-4,5u03b1-epoxy-3-methoxy-17-methylmorphinan-6u03b1-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:
Each tablet contains:Acetaminophen............................300 mgCodeine Phosphate........................15 mg(Warning: May be habit forming)n ORn Acetaminophen............................300 mgCodeine Phosphate........................30 mg(Warning: May be habit forming)n ORn Acetaminophen............................300 mgCodeine Phosphate........................60 mg(Warning: May be habit forming)n In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and stearic acid.

No data

Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain,where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see ], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]

Acetaminophen and codeine phosphate tablets are contraindicated in patients with:n

Addiction, Abuse, and Misuse
An acetaminophen and codeine phosphate tablet contains codeine, a Schedule II controlled substance. As an opioid, acetaminophen and codeine phosphate tablets exposes users to the risks of addiction, abuse, and misuse [see].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed acetaminophen and codeine phosphate tablets. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patientu2019s risk for opioid addiction, abuse, or misuse prior to prescribing acetaminophen and codeine phosphate tablets, and monitor all patients receiving acetaminophen and codeine phosphate tablets for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as acetaminophen and codeine phosphate tablets but use in such patients necessitates intensive counseling about the risks and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing acetaminophen and codeine phosphate tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see n Information for Patients]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patientu2019s clinical status [see]. Carbon dioxide (CO) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of acetaminophen and codeine phosphate tablets the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with and following dosage increases of acetaminophen and codeine phosphate tablets.
To reduce the risk of respiratory depression, proper dosing and titration of acetaminophen and codeine phosphate tablets are essential [see ]. Overestimating the acetaminophen and codeine phosphate tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.
Accidental ingestion of acetaminophen and codeine phosphate tablets, especially by children, can result in respiratory depression and death due to an overdose of codeine.
Neonatal Opioid Withdrawal Syndrome
Prolonged use ofacetaminophen and codeine phosphate tabletsduring pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.u00a0Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see n Information for Patients/Caregivers Pregnancy].

Risks of Driving and Operating Machineryu00a0
Acetaminophen and Codeine Phosphate Tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Acetaminophen and Codeine Phosphate Tablets and know how they will react to the medication [see Information for Patients/Caregivers.
Information for Patients/Caregiversu00a0
Addiction, Abuse, and Misuse
Inform patients that the use of acetaminophen and codeine phosphate tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see ]. Instruct patients not to share acetaminophen and codeine phosphate tablets with others and to take steps to protect acetaminophen and codeine phosphate tabletsfrom theft or misuse.
Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting acetaminophen and codeine phosphate tablets or when the dosage is increased, and that it can occur even at recommended dosages [see ]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see ]. Instruct patients to take steps to store acetaminophen and codeine phosphate tablets securelyu00a0Advise patients to properly dispose of the Acetaminophen and Codeine Phosphate Tablets in accordance with local state guidelines and/or regulations.
Interactions with Benzodiazepines and u00a0Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if acetaminophen and codeine phosphate tablets is used with benzodiazepines or other CNS depressants,including alcohol, and not to use these concomitantly unless supervised by a health care provider [seeu00a0n n n Drug Interactions]n
Serotonin Syndrome
Inform patients thatopioidscould cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications [see Drug Interactions].n n n
Inform patients not to take Acetaminophen and Codeine Phosphate Tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking [TRADENAME] [see W&P or DI].
Arrayn- Array
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see n n n
Important Administration Instructionsu00a0
Instruct patients how to properly take Acetaminophen and Codeine Phosphate Tablets [see n
Maximum Daily Dose of Acetaminophen
Inform patients not to take more than 4,000 milligrams of acetaminophen per day. Advise patients to call their healthcare provider if they have taken more than the recommended dose.
Hypotensionu00a0
Inform patients that Acetaminophen and Codeine Phosphate Tablets may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see WARNINGS; Hypotension].u00a0
Anaphylaxisu00a0
Inform patients that anaphylaxis has been reported with ingredients contained in Acetaminophen and Codeine Phosphate Oral Tablet. Advise patients how to recognize such a reaction, and if they develop signs of allergy such as a rash or difficulty breathing to stop taking Acetaminophen and Codeine Phosphate Oralu00a0Tabletu00a0and seek medical attention. [see ].
Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potentialu00a0that prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [seeu00a0, n n
Embryo-Fetal Toxicity
Inform female patients of reproductive potential that acetaminophen and codeine phosphate tablets can cause fetal harm and to inform the prescriber of a known or suspected pregnancy [seen n ].
Lactation
Advise patients that nursing mothers taking codeine can have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Advise nursing mothers to watch for signs of morphine toxicity in their infants which includes increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the babyu2019s doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services) [see n Nursing Mothers].
Infertilityu00a0
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.
Driving or Operating Heavy Machineryu00a0
Inform patients that Acetaminophen and Codeine Phosphate Tablets may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery and to avoid such tasks while taking this product, until they know how they will react to the medication.
Ultra-Rapid Metabolism of Codeineu00a0
Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid codeine metabolizer or not. These higher-than-normal levels of morphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing. Children with this genetic variation who were prescribed codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. Codeine-containing products are contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving codeine-containing products for other reasons to monitor for signs of respiratory depression.
Disposal of Unused n- Acetaminophen and Codeine Phosphate Tablets
1. Advise patients to properly dispose of the Acetaminophen and Codeine Phosphate Tablets Advise patients to throw the drug in the household trash following these steps. Remove them from their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs).
Drug Interactions
Arrayn- CYP2D6 Inhibitorsu00a0
Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Acetaminophen and Codeine Phosphate Tablets and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but decreased the plasma concentration of active metabolite morphine, particularly when an inhibitor is added after a stable dose of Acetaminophen and Codeine Phosphate Tablet is achieved.u00a0
If concomitant use is necessary, consider dosage adjustment of Acetaminophen and Codeine Phosphate Tablets until stable drug effects are achieved.
After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the codeine plasma concentration will decrease but the morphine plasma concentration will increase. If a CYP2D6 inhibitor is discontinued, consider adjusting the Acetaminophen and Codeine Phosphate Tablets dosage until stable drug effects are achieved.u00a0
If concomitant use is necessary or if a CYP2D6 inhibitor is discontinued after concomitant use, monitor patients closely at frequent intervals. If signs and symptoms of respiratory depression or sedation occur, consider reducing the Acetaminophen and Codeine Phosphate Tablets dosage until stable drug effects are achieved.
Arrayn- CYP3A4 Inhibitorsu00a0
The concomitant use of Acetaminophen and Codeine Phosphate Tablets and CYP3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of codeine, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of Acetaminophen and Codeine Phosphate Tablets is achieved. If concomitant use is necessary, consider dosage reduction of Acetaminophen and Codeine Phosphate Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the codeine plasma concentration will decrease resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine. If a CYP3A4 inhibitor is discontinued, consider increasing the Acetaminophen and Codeine Phosphate Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
Arrayn- CYP3A4 Inducersu00a0
The concomitant use of Acetaminophen and Codeine Phosphate Tablets and CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) can decrease the plasma concentration of codeine, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to codeine. If concomitant use is necessary, consider increasing the Acetaminophen and Codeine Phosphate Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the codeine plasma concentration will increase, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. If a CYP3A4 inducer is discontinued, consider Acetaminophen and Codeine Phosphate Tablets dosage reduction and monitor for signs of respiratory depression.
Arrayn- Array
Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNSu00a0depressants such as alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle
relaxants, general anesthetics,u00a0anti psychotics, and other opioids, can increases the risk ofu00a0respiratory depression, profound sedation, coma, and death.
Arrayn- Array
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [seeu00a0n ].If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue acetaminophen and codeine phosphate tablets if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)u00a0n
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesicsu00a0n
Advise patient to avoid concomitant use of these drugs.u00a0
Muscle Relaxantsu00a0n
Diureticsu00a0n
Anticholinergic Drugsu00a0n
Drug/Laboratory Test Interactionsu00a0n
Arrayn- Carcinogenesisn- Mutagenesisu00a0n- Impairment of Fertilityu00a0n- Infertility
Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [seeu00a0].
Pregnancy
Teratogenic Effects: Pregnancy Category Cu00a0n n- Codeineu00a0
A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100 mg/kg subcutaneous dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring.u00a0There are no adequate and well-controlled studies in pregnant women. Acetaminophen and Codeine Phosphate Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effectsu00a0n n- Fetal/Neonatal Adverse Reactionsu00a0
Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.u00a0Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see n
Arrayn- Array
Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Acetaminophen and codeine phosphate tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including acetaminophen and codeine phosphate, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required [see The effect of codeine, if any, on the later growth, development, and functional maturation of the child is unknown.n
Nursing Mothers
Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeineu2019s active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.u00a0
The developmental and health benefits of breastfeeding should be considered along with the motheru2019s clinical need for Codeine Phosphate Tablets and any potential adverse effects on the breastfed infant from Codeine Phosphate Tablets or from the underlying maternal condition.
The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Infants exposed to codeine phosphate through breast milk should be monitored for excess sedation and respiratory depression. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (See WARNINGS; Death Related to Ultra-Rapid Metabolism of Codeine to Morphine).
Acetaminophen is excreted in breast milk in small amounts, but the significance of its effect on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from acetaminophen, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.u00a0
Infants exposed to Acetaminophen and Codeine Tablets through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.n n
Pediatric Useu00a0
Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy [seen
Geriatric Use
Elderly patients (aged 65 years or older) may have increased sensitivity to acetaminophen and codeine phosphate tablets. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of acetaminophen and codeine phosphate tablets slowly in geriatric patientsu00a0and monitor closely for signs of central nervous system and central nervous system depressionu00a0[seen These drugs are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

The following adverse reactions have been identified during post approval use of Acetaminophen and Codeine Phosphate Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.n u2022 Addiction, Abuse, and Misuse [see ]u00a0u2022 Life-Threatening Respiratory Depression [see ]u00a0u2022 Neonatal Opioid Withdrawal Syndrome [see u00a0u2022 Ultra-rapid Metabolizers of Codeine [see ]u00a0u2022 Interactions with CNS Depressants [see ]u00a0u2022 Severe Hypotension [see]u00a0u2022 Gastrointestinal Adverse Reactions [see ]u00a0u2022 Seizures [see ]u00a0u2022 Withdrawal [see ]u00a0Serious adverse reactions associated with codeine are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.n n The most frequently observed adverse reactions with codeine administration include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation.Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, and agranulocytosis.n n n : faintness, flushing, hypotension, palpitations, syncopeu00a0n abdominal cramps, anorexia, diarrhea, dry mouth, gastrointestinal distress, pancreatitisn anxiety, drowsiness, fatigue, headache, insomnia, nervousness, shakiness, somnolence, vertigo, visual disturbances, weaknessn n rash, sweating, urticarialu00a0n n u2022 Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.u00a0u2022 : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.u00a0u2022 : Anaphylaxis has been reported with ingredients contained in Acetaminophen and Codeine Phosphate Tablets.u00a0u2022 : Cases of androgen deficiency have occurred with chronic use of opioids [see ].u00a0

Controlled Substance
Acetaminophen and codeine phosphate tablet contains acetaminophen and codeine phosphate, a Schedule CII controlled substance.
Abuse
Acetaminophen and codeine phosphate tablet contains u00a0codeine, a substance with a high potential for abuse similar to other opioids includingu00a0fentanyl, hydrocodone, hydrormorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Acetaminophen and Codeine Phosphate Tablets can be abused and is subject to misuse, addiction, and criminal diversion [see .u00a0
All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.
Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful,or potentially harmful,consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.
u201cDrug-seekingu201d behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated u201clossu201d of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating health care provider(s). u201cDoctor shoppingu201d (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.
Acetaminophen and codeine phosphate tablets, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Risks Specific to Abuse of Acetaminophen and Codeine Phosphate Tablets
Acetaminophen and Codeine Phosphate Tablets is for oral use only. Abuse of Acetaminophen and Codeine Phosphate Tablets poses a risk of overdose and death. The risk is increased with concurrent use of Acetaminophen and Codeine Phosphate Tablets with alcohol and other central nervous system depressants.u00a0
Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Arrayn- Array
Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
Acetaminophen and codeine phosphate tablets should not be abruptly discontinued [see ]If acetaminophen and codeine phosphate tablets are abruptly discontinued in a physically dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Pregnancy].

Following an acute overdosage, toxicity may result from codeine or acetaminophen.u00a0n- Clinical Presentationn- Codeineu00a0n- Arrayn- Array
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to acetaminophen and codeine phosphate tablets overdose, administer an opioid antagonist.u00a0In patients who are physically dependent on any opioid agonist including Acetaminophen and Codeine Phosphate Tablets, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.
Because the duration of opioid reversal is expected to be less than the duration of action of acetaminophen and codeine phosphate in acetaminophen and codeine phosphate tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
Acetaminophenu00a0
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation.u00a0
Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.u00a0
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs early in the course of intoxication.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goalsn n
Initiate the dosing regimen for each patient individually; taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see ].
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with acetaminophen and codeine phosphate tablets and adjust the dosage accordingly [see ].
Initial Dosagen n
The usual dosage is:n n
Acetaminophen and Codeine Phosphate Tablets (codeine 15 mg and acetaminophen 300 mg): Take 1 to 2 tablets every 4 hours as needed for pain.u00a0
Acetaminophen and Codeine Phosphate Tablets (codeine 30 mg and acetaminophen 300 mg): Take 1 to 2 tablets every 4 hours as needed for pain.u00a0
Acetaminophen and Codeine Phosphate Tablets (codeine 60 mg and acetaminophen 300 mg): Take one tablet every 4 hours as needed for pain.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours, based upon the above dosage guidance. This information should be conveyed in the prescription.The usual dose of codeine phosphate in children is 0.5 mg/kg. Doses may be repeated up to every 4 hours.
Conversion from Other Opioids to Acetaminophen and Codeine Phosphate Tabletsu00a0n- Arrayn- Acetaminophen and Codeine Phosphate Tablets
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.n n n n
Individually titrate acetaminophen and codeine phosphate tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving acetaminophen and codeine phosphate tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the acetaminophen and codeine phosphate tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of n- acetaminophen and codeine phosphate tablets
u00a0When a patient who has been taking acetaminophen and codeine phosphate tablets regularly and may be physically dependent no longer requires therapy with acetaminophen and codeine phosphate tablets,taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Acetaminophen and Codeine Phosphate Tablets in a physically-dependent patient [see ].

Acetaminophen and codeine phosphate tablets, USP are supplied as follows:n n White to off-white, round, flat-faced, beveled-edged tablets, debossed with u201cU35u201d on one side and plain on the other side.n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n n White to off-white, round, flat-faced, beveled-edged tablets, debossed with u201cU36u201d on one side and plain on the other side.n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Blistercards of 30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDCu00a00615-8102-39u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n n White to off-white, round, flat-faced, beveled-edged tablets, debossed with u201cU37u201d on one side and plain on the other side.n u00a0u00a0u00a0u00a0u00a0u00a0u00a020u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]n Keep this and all medication out of the reach of children.n Protect from moisture. Dispense in a tight, light-resistant container as described in the USP.u00a0n PROTECT FROM LIGHTn n n n n n Aurolife Pharma LLCDayton, NJ 08810n n n Aurobindo Pharma USA, Inc.Dayton, NJ 08810n Revised: 12/2016u00a0LM 2126

MEDICATION GUIDE
Acetaminophenand Codeine Phosphate Tablets, USP CIII
ass-cet-ah-MEE-noe-fenwith KOE-deen FOSS-fate
Acetaminophen and Codeine PhosphateTablets are:
Important information about acetaminophen and codeinephosphate tablets:
Do not take Acetaminophen and Codeine Phosphate Tablets ifyou have:n
u00a0 u00a0u2022
u00a0 u00a0u2022a bowel blockage or narrowing of the stomach or intestines.
u00a0 u2022previously had an allergic reaction to codeine or acetaminophen.
Before taking n- acetaminophen and codeine phosphatetablets, tell your healthcare providerif you have a history of:
Tell your healthcare provider if you are:
When taking Acetaminophen and Codeine Phosphate Tablets:n
u00a0 u00a0 u00a0u2022
u00a0 u00a0 u00a0u2022Take your prescribed dose every 4 hours as needed. Do not take more than your prescribed dose. If you miss a dose, take your next dose u00a0 u00a0 u00a0 u00a0 when needed.
u00a0 u00a0 u2022Call your healthcare provider if the dose you are taking does not control your pain.
u00a0 u00a0u2022If you have been taking Acetaminophen and Codeine Phosphate Tablets regularly, do not stop taking Acetaminophen and Codeine u00a0 u00a0 u00a0 u00a0 u00a0Phosphate Tablets without talking to your healthcare provider.
u00a0 u00a0u2022After you stop taking Acetaminophen and Codeine Phosphate Tablets, to properly dispose of the Acetaminophen and Codeine Phosphate u00a0 u00a0 u00a0Tablets flush it down the toilet or dispose of in accordance with local state guidelines and/or regulations.
While taking n- acetaminophen and codeine phosphate tabletsn- DO NOT:
The possible side effects of n- acetaminophen and codeine phosphatetablets:
Get emergency medical help if you have:
These are not allthe possible side effects of acetaminophen and codeine phosphate tablets. Callyour doctor for medical advice about side effects. You may also request medicalinformation or to report suspected adverse reactions, contact Aurobindo PharmaUSA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088.n
What are the ingredients in Acetaminophen and CodeinePhosphate Tablets?
Active Ingredients:
Inactive ingredients:
This Medication Guide has beenapproved by the U.S. Food and Drug Administration.
Manufacturedby:
Aurolife Pharma LLC
Dayton, NJ 08810
Manufacturedfor:
Aurobindo Pharma USA, Inc.
Dayton, NJ 08810
Revised: 12/2016

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Acetaminophen And Codeine Phosphate (Acetaminophen And Codeine Phosphate)

Trade Name : Acetaminophen and Codeine Phosphate

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Acetaminophen And Codeine Phosphate (Acetaminophen And Codeine Phosphate)

Trade Name : Acetaminophen and Codeine Phosphate

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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