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Pill Identifier Information of APAP 500 MG Oral Tablet

Drug Information

APAP 500 MG Oral Tablet

Imprint: S;500
Shape: C48345
Color: C48325
Ingredients: Acetaminophen
Size: 18.00
Score: 1
Rxtty: SY
Author: HIMPRIT PHARMACHEM PVT LTD
Inactive Ingredients: SODIUM METABISULFITE / SILICON DIOXIDE / CELLULOSE, MICROCRYSTALLINE / CROSCARMELLOSE SODIUM / POLYETHYLENE GLYCOL / STEARIC ACID / TITANIUM DIOXIDE / WATER>

Complete 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code S;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65437-040-311 in 1 DRUM
    131000 in 1 BAG
    2NDC:65437-040-501 in 1 DRUM
    250000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34307/01/2010
    Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)
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