Acetaminophen And Codeine Phosphate (Acetaminophen And Codeine Phosphate)

Trade Name : Acetaminophen and Codeine Phosphate

Apotheca Inc.

SOLUTION

Strength 12012 mg/5mLmg/5mL

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

Delivery Process

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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 Acetaminophen And Codeine Phosphate (Acetaminophen And Codeine Phosphate) which is also known as Acetaminophen and Codeine Phosphate and Manufactured by Apotheca Inc.. It is available in strength of 120; 12 mg/5mL; mg/5mL 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

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • BOXED WARNING
  • 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 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
  • WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
  • 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.
  • Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic.
  • Acetaminophen, 4u2019-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, nonsalicylate 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 5 mL, for oral administration, contains:
  • Acetaminophen 120 mg
  • Codeine Phosphate 12 mg
  • (Warning: May be habit forming)
  • Alcohol 7%
  • In addition the following inactive ingredients are present: artificial cherry flavor, citric acid, FD&C Yellow No. 6, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose.
  • This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen.
  • The behavior of the individual components is described below.
  • Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.
  • Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
  • This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.
  • In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.
  • Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.
  • Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
  • No data
  • The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
  • Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis.
  • At higher doses codeine has most of the disadvantages of morphine including respiratory depression.
  • To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Following an acute overdosage, toxicity may result from codeine or acetaminophen.
  • Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind 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 appreciable increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
  • Acetaminophen and codeine phosphate oral solution contains 120 mg of acetaminophen and 12 mg of codeine phosphate per 5 mL (teaspoonful) and is given orally.
  • The recommended dose of codeine phosphate in children is 0.5 mg/kg of body weight.
  • The usual doses are:
  • Acetaminophen and Codeine Phosphate Oral Solution, USP is an amber colored, cherry flavored solution containing 120 mg acetaminophen and 12 mg codeine phosphate/5 mL supplied in 180mL bottles.
  • Store at15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see Controlled Room Temperature].
  • Protect from light. Do not refrigerate.
  • Dispense in tight, light-resistant container as defined in the official compendium.
  • Rx only
  • HI-TECH PHARMACAL CO., INC.
  • Amityville, NY 11701
  • Phoenix, AZ 85006
  • No data

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