Acetaminophen Tablet, Film Coated
FDA Label NDC 49483-342

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc for the product Acetaminophen (NDC 49483-342). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Acetaminophen 500 mg


Otc - Purpose

PURPOSE:  Pain Reliever - fever reducer

Otc - Keep Out Of Reach Of Children

Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away

Indications & Usage

INDICATIONS AND USAGE:

Pain Reliever – temporarily relieves minor aches and pains  due to:  the common cold, headache, backache, muscular aches,  toothache, premenstrual and menstrual cramps, minor pain of arthritis. Temporarily reduces fever.

Warnings

Warnings;
Liver warning:  This product contains acetaminophen.  Severe liver damage may occur if you take:more than 8 tablets in 24 hours, which is the maximum daily amount; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen.

Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage.  in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.



Dosage & Administration

Do not take more than directed (see overdosage warning)

Adults and children 12 years and over:  take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor; do not take for more than 10 days unless directed by a doctor

Children under 12 years:  Do not use this adult extra strength product in children under 12 years of age, this will provide more than the recommended dose (overdosage) of acetaminophen and may cause liver damage



Inactive Ingredient

CARNAUBA WAX, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, POLYETHYLENE GLYCOL(PEG) 400, POLYETHYLENE GLYCOL (peg) 8000, POVIDONE, PREGELATINIZED STARCH, SODIUM STARCH GLYCOLATE**, STEARIC ACID, SUCRALOSE, TITANIUM DIOXIDE



** MAY CONTAIN THIS INGREDIENT

Package Label.Principal Display Panel

342label (342)

342label (342)

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