Hydrocodone Bitartrate And Acetaminophen (Hydrocodone Bitartrate And Acetaminophen)

Trade Name : Hydrocodone Bitartrate and Acetaminophen

VistaPharm, Inc.

SOLUTION

Strength 2.5108 mg/5mLmg/5mL

HYDROCODONE BITARTRATE; ACETAMINOPHEN Opioid Agonist [EPC],Opioid Agonists [MoA]

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hydrocodone Bitartrate And Acetaminophen (Hydrocodone Bitartrate And Acetaminophen) which is also known as Hydrocodone Bitartrate and Acetaminophen and Manufactured by VistaPharm, Inc.. It is available in strength of 2.5; 108 mg/5mL; mg/5mL per ml. Read more

Hydrocodone Bitartrate And Acetaminophen (Hydrocodone Bitartrate And Acetaminophen) 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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About GNH

No data

Revised: August 2019

Arrayn- WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Arrayn- Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Bitartrate and Acetaminophen Oral Solution. Dosing errors due to confusion between mg and mL, and other Hydrocodone Bitartrate and Acetaminophen Oral Solutions of different concentrations can result in accidental overdose and death [see , ].
Arrayn- Addiction, Abuse, and Misuse
Hydrocodone Bitartrate and Acetaminophen Oral Solution exposes 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 Hydrocodone Bitartrate and Acetaminophen Oral Solution, and monitor all patients regularly for the development of these behaviors and conditions [see ].
Arrayn- Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction,u00a0abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see ]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
Arrayn- Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Acetaminophen Oral Solution. Follow patients for signs of respiratory depression, especially during initiation of Hydrocodone Bitartrate and Acetaminophen Oral Solution or following a dose increase [see ].
Arrayn- Accidental Ingestion
Accidental ingestion of Hydrocodone Bitartrate and Acetaminophen Oral Solution, especially by children, can result in a fatal overdose of Hydrocodone Bitartrate and Acetaminophen Oral Solution [see ].
Arrayn- Neonatal Opioid Withdrawal Syndrome
Prolonged use of Hydrocodone Bitartrate and Acetaminophen Oral Solution 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 [seeu00a0].
Arrayn- Cytochrome P450 3A4 Interaction
The concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution with all Cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used Cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Follow patients receiving Hydrocodone Bitartrate and Acetaminophen Oral Solution and any Cytochrome P450 3A4 inhibitor or inducer for signs and symptoms of respiratory depression and sedation [see , , ].
Arrayn- Hepatotoxicity
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 , ].
Arrayn- Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see , ].

Hydrocodone bitartrate and acetaminophen is available in liquid form for oral administration.
Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5u03b1-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:
CHNOu2022 CHOu2022 2u00bd HOu00a0u00a0u00a0u00a0 M.W. 494.490
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
CHNOu00a0u00a0u00a0u00a0u00a0 MW = 151.16
In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben (preservative), propylene glycol, propylparaben (preservative), purified water, saccharin sodium,u00a0sodium citrate dihydrate, sorbitol solution, sucrose, FD&C Red #40 as coloring and artificial wild cherry as flavoring.

No data

Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic 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 Hydrocodone Bitartrate and Acetaminophen Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

Hydrocodone Bitartrate and Acetaminophen Oral Solution is contraindicated in patients with:

No data

No data

Inhibitorsn- of CYP3A4 and CYP2D6
The concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution 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 hydrocodone from Hydrocodone Bitartrate and Acetaminophen Oral Solution, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution and both CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution is achieved [see ].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, hydrocodone plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Oral Solution.
If concomitant use is necessary, consider dosage reduction of Hydrocodone Bitartrate and Acetaminophen Oral Solution until stable drug effects are achieved. Follow patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage until stable drug effects are achieved. Follow patients for signs or symptoms of opioid withdrawal.
Inducersn- of CYP3A4
The concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of hydrocodone [seeu00a0], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to [see ].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [seeu00a0n ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use is necessary, consider increasing the Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage until stable drug effects are achieved [see ]. Follow for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage reduction and monitor for signs of respiratory depression.
Benzodiazepinesn- and Other CNS Depressants
Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants such as benzodiazepines and other sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].
Serotonergicn- 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 affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), 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. [see ].
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Hydrocodone Bitartrate and Acetaminophen Oral Solution if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, or linezolid, may manifest as serotonin syndrome, or opioid toxicity (e.g., respiratory depression, coma) [see ].
The use of Hydrocodone Bitartrate and Acetaminophen Oral Solution is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of Hydrocodone Bitartrate and Acetaminophen Oral Solution and/or precipitate withdrawal symptoms.
Advise patient to avoid concomitant use of these drugs.
Muscle Relaxants
Hydrocodone Bitartrate and Acetaminophen Oral Solution may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
If concomitant use is warranted, follow patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Hydrocodone Bitartrate and Acetaminophen Oral Solution and/or the muscle relaxant as necessary.
Diuretics
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
If concomitant use is warranted, follow patients for signs of urinary retention or reduced gastric motility when Hydrocodone Bitartrate and Acetaminophen Oral Solution are used concomitantly with anticholinergic drugs.

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets and oral solution. 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.
The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. Other adverse reactions include:
Cardio-Renal:u00a0
Central Nervous System/Psychiatric:u00a0
Endocrine:u00a0
Gastrointestinal System:u00a0
Genitourinary System:u00a0
Hematologic:u00a0
Hypersensitivity:u00a0
Musculoskeletal:u00a0
Respiratory Depression:u00a0n- Array
Special Senses:u00a0
Skin:u00a0

No data

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
Clinical Presentation
Acute overdosage with Hydrocodone Bitartrate and Acetaminophen Oral Solution can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Acetaminophen
Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
Treatment of Overdose
Hydrocodone
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 techniques.
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 Hydrocodone Bitartrate and Acetaminophen Oral Solution overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to Hydrocodone Bitartrate and Acetaminophen Oral Solution overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone in Hydrocodone Bitartrate and Acetaminophen Oral Solution carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
Acetaminophen
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease absorption if acetaminophen is known or suspected to have occurred within a few hours of presentation. 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 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.
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 in the course of intoxication.

No data

Hydrocodone Bitartrate and Acetaminophen Oral Solution
With alcohol content of 8.6% v/v. It is supplied in the following containers:
NDC 66689-004-50: Case contains 50 unit-dose cups of 5 mL (NDC 66689-004-01), packaged in 5 trays of 10 unit-dose cups each.
NDC 66689-005-50: Case contains 50 unit-dose cups of 10 mL (NDC 66689-005-01), packaged in 5 trays of 10 unit-dose cups each.
NDC 66689-023-50: Case contains 50 unit-dose cups of 15 mL (NDC 66689-023-01), packaged in 5 trays of 10 unit-dose cups each.
NDC 66689-023-04: Bottles of 4 fl. oz. (120 mL).
NDC 66689-023-16: Bottles of 16 fl. oz. (473 mL).

Manufactured by:
VistaPharmn Largo, FL 33771, USA
VP2017R710/19

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Hydrocodone Bitartrate
and Acetaminophen
Oral Solution, n
2.5 mg/108 mg per 5 mL u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0
Contains Alcohol 8.6% v/v
PHARMACIST: Dispense the enclosed
Medication Guide to each patient.
Delivers 5 mL
Store at 20u00b0-25u00b0C (68u00b0-77u00b0F); see USP CRT conditions.
Arrayn- XacTDosen
Manufactured by:u00a0
Arrayn- VistaPharmu00ae
Largo, FL 33771, USA
Rx Only
u00a0
08/19
NDC 66689-004-01

Hydrocodone Bitartrate
and Acetaminophen
Oral Solution,u00a0n
5 mg/217 mg per 10 mL u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0
Contains Alcohol 8.6% v/v
PHARMACIST: Dispense the enclosed
Medication Guide to each patient.
Delivers 10 mL
Store at 20u00b0-25u00b0C (68u00b0-77u00b0F); see USP CRT conditions.
XacTDosen
Manufactured by:u00a0
Arrayn- VistaPharmu00ae
Largo, FL 33771, USA
Rx Only
VP2230R2
08/19
NDC 66689-005-01

Hydrocodone Bitartrateu00a0
and Acetaminophenu00a0
Oral Solution, n
7.5 mg/325 mg per 15mL u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0
Contains Alcohol 8.6% v/v
PHARMACIST:Dispense the enclosed
Medication Guide to each patient.
Delivers 15 mL
u00a0
Arrayn- XacTDosen
Manufactured by:u00a0
Arrayn- VistaPharm
Largo, FL 33771, USA
Rx Only
VP2020R5
08/19
NDC 66689-023-01

NDC 66689-023-04
HYDROCODONE BITARTRATE AND
ACETAMINOPHEN ORALu00a0SOLUTION, CII
7.5 mg/325 mg per 15 mL
(Cherry Flavored)
PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATIONGUIDE TO EACH PATIENT.
Contains: u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Per 5 mL u00a0 u00a0 u00a0Per 15 mL
Hydrocodone Bitartrate.............................2.5 mg.........7.5 mg
WARNING: May be habit-forming
Acetaminophen...........................................108 mg.......325 mg
Alcohol.........................................................8.6%v/v.........8.6%v/v
120 mL
Rx Only
Arrayn- VistaPharmn
VP2139R4
07/18

NDC 66689-023-04
HYDROCODONE BITARTRATE AND
ACETAMINOPHEN ORALu00a0SOLUTION, CII
7.5 mg/325 mg per 15 mL
(Cherry Flavored)
PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATIONGUIDE TO EACH PATIENT.
Contains: u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Per 5 mL u00a0 u00a0 u00a0Per 15 mL
Hydrocodone Bitartrate.............................2.5 mg.........7.5 mg
WARNING: May be habit-forming
Acetaminophen...........................................108 mg.......325 mg
Alcohol.........................................................8.6%v/v.........8.6%v/v
120 mL
Rx Only
Arrayn- VistaPharmn
VP2263R1
04/19

NDC 66689-023-16
HYDROCODONE BITARTRATE ANDn- ACETAMINOPHEN ORAL SOLUTION, CII
7.5 mg/325 mg per 15mL
PHARMACIST: DISPENSE THE ACCOMPANYINGMEDICATION GUIDE TO EACH PATIENT.
Contains: u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 Per 5 mL u00a0 u00a0 u00a0 Per 15 mL
Hydrocodone Bitartrate................................2.5 mg........7.5 mgn n Acetaminophen...........................................108 mg.......325 mgAlcohol........................................................8.6%v/v......8.6%v/v
473 mL
DO NOT USE IF SEAL UNDER CAP ISMISSING OR APPEARS TO BE BROKENn
Rx Only
u00a0n- Array
VP2021R3
07/18
Arrayn- Array

NDC 66689-023-16
HYDROCODONE BITARTRATE ANDn- ACETAMINOPHEN ORAL SOLUTION, CII
7.5 mg/325 mg per 15mL
PHARMACIST: DISPENSE THE ACCOMPANYINGMEDICATION GUIDE TO EACH PATIENT.
Contains: u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 Per 5 mL u00a0 u00a0 u00a0 Per 15 mL
Hydrocodone Bitartrate................................2.5 mg........7.5 mgn n Acetaminophen...........................................108 mg.......325 mgAlcohol........................................................8.6%v/v......8.6%v/v
473 mL
Rx Only
Arrayn- Array
VP2264
07/18

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Hydrocodone Bitartrate And Acetaminophen (Hydrocodone Bitartrate And Acetaminophen)

Trade Name : Hydrocodone Bitartrate and Acetaminophen

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Hydrocodone Bitartrate And Acetaminophen (Hydrocodone Bitartrate And Acetaminophen)

Trade Name : Hydrocodone Bitartrate and Acetaminophen

SOLUTION

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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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Canadian DIN

Swiss Drugs

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