Label: ASPIRIN- aspirin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/14

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Chewable

    Low Dose

    Orange Flavor

    Aspirin Regimen**

    Gluten Free

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  • Purpose

    Pain reliever

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  • Uses

    for the temporary relief of minor aches and pains

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  • Directions

    •drink a full glass of water with each dose
    •adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
    •children under 12 years: consult a doctor
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  • Other information

    •store at 20-25°C (68-77°F)

    COMPARE TO the active ingredient of BAYER® CHEWABLE ASPIRIN ***

    ***Major® Aspirin 81 mg is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer Chewable A

    Gluten Free

    Bulk Manufacturer NDC 0904-4040-73

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  • Inactive ingredients

    corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium

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  • Questions or comments?

    1-800-616-2471

    Distributed by

    MAJOR PHARMACEUTICALS

    31778 Enterprise Drive

    Livonia, MI 48150 USA

    Rev. 11/11

    Repackaged by Cardinal Health

    Zanesville, OH 43701

    IE70130713

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  • Principal Display Panel

    Aspirin

    Pain Reliever (NSAID) tablets

    81 mg

    Contains Approximately 2052 Tablets

    Bottle Label
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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-0748(NDC:0904-4040)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SACCHARIN (UNII: FST467XS7D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 8mm
    Flavor ORANGE Imprint Code L467
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-0748-8 2052 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 05/23/2011
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-0748)
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