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ACETAMINOPHEN

HIMPRIT PHARMACHEM PVT LTD

ACETAINOPHEN TABLETS USP 500 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each Caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

ACETAMINOPHEN Uses

Temporarily relieves minor aches and pains due to :

headache
  • backache
  • the common cold
  • menstrual crampsmuscular 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.

    ACETAMINOPHEN 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"

    ACETAMINOPHEN

    ACETAMINOPHEN

    ACETAMINOPHEN TABLET, FILM COATED

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:65437-040
    Route of Administration ORAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN ACETAMINOPHEN 500 mg

    Inactive Ingredients

    Ingredient Name Strength
    SODIUM METABISULFITE
    SILICON DIOXIDE
    cellulose, microcrystalline
    CROSCARMELLOSE SODIUM
    polyethylene glycol
    STEARIC ACID
    titanium dioxide
    water

    Product Characteristics

    Color Size Imprint Code Shape
    WHITE 18 mm S;500 OVAL

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 31000 in 1 BAG
    2 50000 in 1 BAG
    3 NDC:65437-040-50 1 in 1 DRUM

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part343 2010-07-01


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    Be sure to consult your doctor before taking any medication!
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