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ACETAMINOPHEN (HIMPRIT PHARMACHEM PVT LTD)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BAG in 1 DRUM (65437-040-31) > 31000 TABLET, FILM COATED in 1 BAG Label Information
TABLET, FILM COATED 1 BAG in 1 DRUM (65437-040-50) > 50000 TABLET, FILM COATED in 1 BAG Label Information

Complete ACETAMINOPHEN Information

  • SPL UNCLASSIFIED SECTION

    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 cramps
    *
    • muscular aches
    *
    • arthritis
    *
    • toothache
    *
    • reduces fever

  • Warnings

    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.

    Do not use

    *
    • with any other product containing acetaminophen

    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

    If pregnant or breast-feeding, ask a health professional before use

    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

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65437-040
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code S;500
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65437-040-31 1 in 1 DRUM
    1 31000 in 1 BAG
    2 NDC:65437-040-50 1 in 1 DRUM
    2 50000 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 07/01/2010
    Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)