Acetaminophen And Codeine Phosphate Solution

Acetaminophen And Codeine Phosphate Solution

Acetaminophen And Codeine Phosphate Solution Recall

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Questions & Answers

Side Effects & Adverse Reactions

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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/Anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue acetaminophen and codeine phosphate oral solution immediately and seek medical care if they experience these symptoms. Do not prescribe acetaminophen and codeine phosphate oral solution for patients with acetaminophen allergy.

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.

History

There is currently no drug history available for this drug.

Other Information

Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic.

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:

Chemical Structure

Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

Chemical Structure

Each 5 mL, for oral administration, contains:

Acetaminophen120 mg
Codeine Phosphate12 mg
Alcohol7%  

INACTIVE INGREDIENTS: FD&C Red No. 40, FD&C Yellow No. 6 (Sunset Yellow), flavoring, glycerin, propylene glycol, purified water, sodium saccharin, and sucrose.

Acetaminophen And Codeine Phosphate Solution Manufacturers


  • A-s Medication Solutions Llc
    Acetaminophen And Codeine Phosphate Solution [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine Phosphate Solution [A-s Medication Solutions Llc]
  • Apotheca, Inc.
    Acetaminophen And Codeine Phosphate Solution [Apotheca, Inc.]
  • Actavis Mid Atlantic Llc
    Acetaminophen And Codeine Phosphate Solution [Actavis Mid Atlantic Llc]
  • Stat Rx Usa Llc
    Acetaminophen And Codeine Phosphate Solution [Stat Rx Usa Llc]
  • Rebel Distributors Corp.
    Acetaminophen And Codeine Phosphate Solution [Rebel Distributors Corp.]
  • Physicians Total Care, Inc.
    Acetaminophen And Codeine Phosphate Solution [Physicians Total Care, Inc.]
  • Redpharm Drug Inc.
    Acetaminophen And Codeine Phosphate Solution [Redpharm Drug Inc.]
  • Pharmaceutical Associates, Inc.
    Acetaminophen And Codeine Phosphate Solution [Pharmaceutical Associates, Inc.]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine Phosphate Solution [A-s Medication Solutions Llc]
  • Cardinal Health
    Acetaminophen And Codeine Phosphate Solution [Cardinal Health]
  • Qualitest Pharmaceuticals
    Acetaminophen And Codeine Phosphate Solution [Qualitest Pharmaceuticals]
  • Aidarex Pharmaceuticals Llc
    Acetaminophen And Codeine Phosphate Solution [Aidarex Pharmaceuticals Llc]
  • Hi-tech Pharmacal Co., Inc.
    Acetaminophen And Codeine Phosphate Solution [Hi-tech Pharmacal Co., Inc.]
  • Morton Grove Pharmaceuticals, Inc.
    Acetaminophen And Codeine Phosphate Solution [Morton Grove Pharmaceuticals, Inc.]
  • Cardinal Health
    Acetaminophen And Codeine Phosphate Solution [Cardinal Health]
  • Preferred Pharmaceuticals, Inc.
    Acetaminophen And Codeine Phosphate Solution [Preferred Pharmaceuticals, Inc.]
  • Atlantic Biologicals Corps
    Acetaminophen And Codeine Phosphate Solution [Atlantic Biologicals Corps]
  • A-s Medication Solutions Llc
    Acetaminophen And Codeine Phosphate Solution [A-s Medication Solutions Llc]
  • Proficient Rx Lp
    Acetaminophen And Codeine Phosphate Solution [Proficient Rx Lp]

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