Label: ASPIRIN 325MG- aspirin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 23, 2016

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

  • ACTIVE INGREDIENT

    Aspirin USP (NSAID) 325 mg

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  • PURPOSE

    Pain Reliever

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  • INDICATIONS & USAGE

    Uses:

    For the relief of:

    • headache • minor aches and pains

    • for reduction of fever of colds and flu

    • menstrual discomfort • toothache

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  • WARNINGS

    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.

    Stomach Bleeding:

    This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • PREGNANCY OR BREAST FEEDING

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

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  • OVERDOSAGE

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

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  • DOSAGE & ADMINISTRATION

    Directions:

    Do not use more than directed.

    Adults and children 12 years of age and older: 1 to 2 tablets every 4 hours, do not exceed 12 tablets in 24 hours.

    Children under 12 consult a physician.

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  • INACTIVE INGREDIENT

    SEE ORIGINAL BOX FOR COMPLETE

    PRODUCT INFORMATION

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 325MG 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-0232
    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
    POVIDONE K30 (UNII: U725QWY32X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white (SNOW WHITE) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code FR21
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51532-0232-2 2 in 1 PACKET; Type 0: Not a Combination Product 10/25/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 03/31/2015
    Labeler - Afassco Inc. (609982723)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    Name Address ID/FEI Business Operations
    Ultraseal Corporation 085752004 pack(51532-0232)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(51532-0232)
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