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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Time Cap Laboratories, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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