ACETAMINOPHEN AND CODEINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Available from:

Proficient Rx LP

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain. Codeine-containing products are contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Acetaminophen and Codeine Phosphate Tablets should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. Click here to enter Use in Specific Populations Click here to enter Pregnancy Click here to enter Lactation Click here to enter Females and Males of Reproductive Potential Click here to enter Pediatric Use Click here to enter Geriatric Use Controlled Substance Acetaminophen and Codeine Phosphate Tablets are classified as a Schedule III controlled substance. Drug Abuse and Dependence Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence and tolerance may develop upon repeated administration, and i

Product summary:

Acetaminophen and Codeine Phosphate Tablets, USP 300 mg /30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse. They are available as follows: Bottles of 20:   NDC 63187-491-20 Bottles of 30:   NDC 63187-491-30 Bottles of 60 : NDC 63187-491-60 Bottles of 90 : NDC 63187-491-90 Store Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM-5PM EST Manufactured by: Amneal Pharmaceuticals Hauppauge, NY 11788 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. 10-2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
[ENTER DRUG NAME] SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR [ENTER DRUG NAME].
INITIAL U.S. APPROVAL: [ENTER YEAR]
RECENT MAJOR CHANGES
Click here to enter Recent Major Changes
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO
MORPHINE
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Nursing Mothers
*
Sections or subsections omitted from the full prescribing information
are not listed.
FULL PRESCRIBING INFORMATION
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.
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