Acetaminophen and Codeine description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Acetaminophen and Codeine

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.


ACETAMINOPHEN AND CODEINE DESCRIPTION



Acetaminophen and Codeine


Acetaminophen and Codeine










CLINICAL PHARMACOLOGY



Pharmacokinetics:


Codeine:



OVERDOSAGE

Acetaminophen:

OVERDOSAGE

INDICATIONS & USAGE



ACETAMINOPHEN AND CODEINE CONTRAINDICATIONS



WARNINGS

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 Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Acetaminophen and Codeine Phosphate Tablets, USP for patients with acetaminophen allergy.






PRECAUTIONS

General:


Ultra-Rapid Metabolizers of Codeine


PRECAUTIONS - Nursing Mothers

INFORMATION FOR OWNERS/CAREGIVERS


  • ●      Do not take Acetaminophen and Codeine Phosphate Tablets, USP if you are allergic to any of its ingredients.
  • ●     If you develop signs of allergy such as a rash or difficulty breathing stop taking Acetaminophen and Codeine Phosphate Tablets, USP and contact your healthcare provider immediately.
  • ●     Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.






LABORATORY TESTS



DRUG INTERACTIONS



DRUG & OR LABORATORY TEST INTERACTIONS




CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY




PREGNANCY

Teratogenic Effects: Pregnancy Category C:




Nonteratogenic Effects:


LABOR & DELIVERY

OVERDOSAGE

NURSING MOTHERS




PRECAUTIONS - General - Ultra-Rapid Metabolizers of Codeine

ACETAMINOPHEN AND CODEINE ADVERSE REACTIONS





DRUG ABUSE AND DEPENDENCE

Controlled Substance:


Abuse and Dependence:


OVERDOSAGE



Signs and Symptoms:



Treatment:





DOSAGE & ADMINISTRATION







HOW SUPPLIED




STORAGE AND HANDLING




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Acetaminophen and Codeine

Acetaminophen and Codeine

Acetaminophen and Codeine

Acetaminophen and Codeine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-926(NDC:0603-2339)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 300 mg
CODEINE PHOSPHATE CODEINE ANHYDROUS 60 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
povidone
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM METABISULFITE
STEARIC ACID
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
white 12 mm 2065;V;4 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-926-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089828 2012-03-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.