Label: CHEWABLE ASPIRIN ADULT LOW DOSE- aspirin tablet, chewable

  • 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 April 17, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Aspirin 81 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Purposes
    Pain reliever

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  • INDICATIONS & USAGE

    Uses ■ for the temporary relief of minor aches and pains or as
    recommended by your doctor

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  • WARNINGS

    Warnings
    Reye’s syndrome: Children and teenagers who have or are recovering
    from chicken pox or flu-like symptoms should not use this product.
    When using this product, if changes in behavior with nausea and
    vomiting occur, consult a doctor because these symptoms could be an
    early sign of Reye’s syndrome, a rare but serious illness.
    Allergy alert: Aspirin may cause a severe allergic reaction, which may
    include: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing)
    Stomach bleeding warning: This product contains an NSAID, which
    may cause severe stomach bleeding. The chance is higher if you:
    ■ are age 60 or older ■ have had stomach ulcers or bleeding problems
    ■ take a blood thinning (anticoagulant) or steroid drug

    ■ take other drugs containing prescription or nonprescription NSAIDs
    (aspirin, ibuprofen, naproxen or others)
    ■ have 3 or more alcoholic drinks every day while using this product
    ■ take more or for a longer time than directed

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  • DO NOT USE

    Do not use ■ if you are allergic to aspirin or any other pain
    reliever/fever reducer ■ this product for at least 7 days after
    tonsillectomy or oral surgery unless directed by a doctor
    ■ if you have ever had an allergic reaction to this product or any of its
    ingredients

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  • 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

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription
    drug for ■ gout ■ diabetes ■ arthritis

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  • STOP USE

    Stop use and ask a doctor if ■ an allergic reaction occurs.
    Seek medical help right away ■ you experience any of the following
    signs of stomach bleeding: ■ feel faint ■ vomit blood
    ■ have bloody or black stool ■ have stomach pain that does not get
    better ■ pain gets worse or lasts more than 10 days ■ redness
    or swelling is present ■ new symptoms occur ■ ringing in the ears
    or loss of hearing occurs

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  • 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 specifically directed to do so by a doctor
    because it may cause problems in the unborn child or
    complications during delivery.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information
    ■ store at room temperature

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  • INACTIVE INGREDIENT

    Inactive ingredients
    corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor,
    saccharin sodium

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  • QUESTIONS

    Questions or comments?
    Call toll free 1-800-MEDLINE (633-5463)
    Monday-Friday 9AM-5PM CST

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  • INGREDIENTS AND APPEARANCE
    CHEWABLE ASPIRIN ADULT LOW DOSE 
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-020
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    DEXTRATES (UNII: G263MI44RU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color orange Score score with uneven pieces
    Shape ROUND Size 7mm
    Flavor ORANGE Imprint Code AZ;013
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-020-28 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/17/2018
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/17/2018
    Labeler - Medline Industries (025460908)
    Establishment
    Name Address ID/FEI Business Operations
    Medline Industries, Inc. 079800021 repack(53329-020)
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