Label: ASPIRIN LOW DOSE ENTERIC COATED- aspirin tablet

  • 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 July 16, 2010

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  • ACTIVE INGREDIENT

    Enter section text here

    Drug Facts
    Active ingredient (in each tablet) Purpose
    Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
    *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Uses • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more
    than 10 days without consulting your doctor because
    serious side effects may occur Close
  • ASK DOCTOR

    Ask a doctor before use if • stomach bleeding warning
    applies to you • you have a history of stomach
    problems, such as heartburn • you have high blood
    pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic • you have asthma • you
    have not been drinking fluids • you have lost a lot of
    fluid due to vomiting or diarrhea
    Ask a doctor or pharmacist before use if you are
    • taking a prescription drug for diabetes, gout, or arthritis
    • under a doctor’s care for any serious condition
    • taking any other drug Close
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    • taking a prescription drug for diabetes, gout, or arthritis
    • under a doctor’s care for any serious condition
    • taking any other drug Close
  • PREGNANCY OR BREAST FEEDING

    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. Close
  • PRINCIPAL DISPLAY PANEL

    IMAGE OF BULK LABELEnter section text here

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE ENTERIC COATED
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-390
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E) aspirin 81 mg
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code embossed;A;lower;plain
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-390-00 100000 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 07/16/2010
    Labeler - Time-Cap Labs, Inc (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    Time-Cap Labs, Inc 037052099 manufacture
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