Label: ASPIRIN- aspirin tablet, film coated

  • NDC Code(s): 65437-038-05, 65437-038-07, 65437-038-10
  • Packager: HIMPRIT PHARMACHEM PVT LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 8, 2010

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Aspirin 325 mg

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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    temporarily relieves

    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • pain and fever of colds
    • minor pain of arthritis
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  • Warnings

    Reye's syndrome

    Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

    Allergy alert

    Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Alcohol warning

    If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

    Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

    Ask a doctor before use if you have

    • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
    • bleeding problems
    • ulcers
    • asthma

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    • anticoagulation (blood thinning)
    • gout
    • diabetes
    • arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • fever lasts more than 3 days
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
    • children under 12 years: consult a doctor
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  • Other information

    • save carton for full directions and warnings
    • store at room temperature
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  • Inactive ingredients

    carnauba wax1, corn starch, hypromellose, powdered cellulose, triacetin


    1
    may contain this ingredient
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  • PRINCIPAL DISPLAY PANEL

    ASPIRIN 325 MG TABLETS
    Each Film coated Tablet Contains:

    ASPIRIN 325 MG

    Lot No :
    MFG. DATE :
    Exp. Date :
    Jar No. :
    Quantity : 50,000 Tablets
    NDC. No : 65437-038-05

    WARNING :
    KEEP OUT OF THE REACH OF CHILDREN

    STORE CONTROLLED ROOM TEMPERATURE 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
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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65437-038
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65437-038-05 1 in 1 DRUM
    1 50000 in 1 BAG
    2 NDC:65437-038-07 1 in 1 DRUM
    2 75000 in 1 BAG
    3 NDC:65437-038-10 1 in 1 DRUM
    3 100000 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 03/01/2010
    Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)
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