Label: MEDIQUE PRODUCTS CHEWABLE LOW DOSE ASPIRIN- aspirin tablet, chewable

  • NDC Code(s): 47682-038-46
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 26, 2024

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

  • Drug Facts

    Drug Facts

  • Active ingredient

    Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Purpose

    Pain reliever

  • Uses

    Uses

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

  • 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

    ■ asthma (wheezing)

    ■ shock

    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 alcohol drinks every day while using this product

    ■ take more or for a longer time than directed

  • Do not use

    Do not use

    • if you are allergic to aspirin or to 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
  • Ask a doctor before use if

    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

  • Ask a doctor or pharmacist before use if you are

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

    ■ gout

    ■ diabetes

    ■ arthritis

  • Stop use and ask a doctor if

    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 stools

    ■ have stomach pain that does not get better

    ■ pain gets worse or lasts more than 10 days

    ■ ringing in the ears or loss of hearing occurs

    ■ redness or swelling is present

    ■ new symptoms occur

  • If pregnant 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 if may cause problems in the unborn child or complications during delivery.

  • 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 (1-800-222-1222) right away.

  • Directions

    Directions

    ■ drink a full glass of water with each

    Adults and children 12 years and over:

    take 4 or 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

  • Other information

    Other information

    ■ store at room temperature

    ■ tamper evident sealed packets

    ■ do not use any opened or torn packets

  • Inactive ingredients

    Inactive ingredients

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

  • Questions or comments?

    Questions or comments? 1-800-634-7680

  • Medique Chewable Low Dose Aspirin 81 mg

    Medique®

    Chewable Low Dose

    Aspirin

    81 mg

    Pain reliever (NSAID*)

    *nonsteroidal anti-inflammatory drug

    THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

    **Talk to your doctor or other healthcare provider

    before using this product for your heart.

    Compare active ingredient to Bayer® Chewable Low Dose Aspirin

    Registered Trademark Bayer Consumer

    Tamper Evident Unit Dose Packets

    24

    Tablets

    (24 x 1)

    140B Chewable Aspirin 14064

  • INGREDIENTS AND APPEARANCE
    MEDIQUE PRODUCTS CHEWABLE LOW DOSE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-038
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTRATES (UNII: G263MI44RU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize7mm
    FlavorORANGEImprint Code AZ013
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-038-4624 in 1 BOX04/26/2024
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/26/2024
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(47682-038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794pack(47682-038)