Acetaminophen
FDA Label NDC 65437-040

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Himprit Pharmachem Pvt Ltd for the product Acetaminophen (NDC 65437-040). 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 other, active ingredients (in each caplet), purpose, uses, overdose warning, alcohol warnings, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients (In Each Caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

Temporarily relieves minor aches and pains due to :

headache
  • backache
  • the common cold
  • menstrual crampsmuscular aches
  • arthritis
  • toothache
  • reduces fever
    ****
    ****

    Overdose Warning

    Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even you do not notice any signs or symptoms.

    Alcohol Warnings

    If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

    Otc - Do Not Use

    Do not use

    • *with any other product containing acetaminophen

    Otc - Stop Use

    Stop use and Ask a doctor if

    • *fever gets worse or lasts for more than 3 days
    • *redness or swelling is present
    • *pain gets worse or lasts for more than 10 days
    • *new symptoms occur

    Otc - Keep Out Of Reach Of Children

    Keep out of reach of children.

    Direction

    • *do not use more that directed (see overdose warning)
    • *adults and children 12 years and over : take 2 caplets every 6 hours as needed
    • *do not take more than 8 caplets in 24 hours
    • *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 (overdose) and could cause serious health problems.

    Other Information

    • *Store at room temperature

    Inactive Ingredients

    croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate

    Principal Display Panel - 500 Mg Tablet Shipper Label

    ACETAMINOPHEN TABLETS USP 500 mg
    Each Film coated Tablet Contains:
    ACETAMINOPHEN 500 MG

    Lot No :
    MFG. DATE :
    Exp. Date :
    Jar No. :
    Quantity : 31000 Tablets
    NDC. No : 65437-040-31

    WARNING :
    KEEP OUT OF THE REACH OF CHILDREN

    STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
    CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

    MANUFACTURED BY:
    MANUFACTURED CODE No Guj/Drugs/G/1362
    LABELER CODE # 14803

    MANUFACTURED FOR:
    HIMPRIT PHARMACHEM PVT. LTD
    "LAKULISH", R.V.DESAI ROAD,
    NEXT TO NAVAPURA POLICE STATION
    BARODA, INDIA – 390 001

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    Principal Display Panel (500 mg Tablet Shipper Label)

    Principal Display Panel (500 mg Tablet Shipper Label)

    * Please review the disclaimer below.