Label: ASPIRIN suppository

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated April 30, 2022

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  • Active ingredient

    Aspirin Suppositories, USP 300 mg (5 grains)

    Each suppository contains 300 mg (5 grains) of aspirin.

  • Indications:

    For the relief of minor aches, pains and headache and for reduction of fever.

  • Directions

    Remove suppository from plastic packet and insert into the rectum as far as possible. Adult: One suppository every 4 hours for no more than 10 days or as directed by a physician. Children under 12 years of age: Consult a physician.

  • Caution:

    Suppositories sealed in imprinted plastic packet. Do not use if imprinted packet is opened or damaged.

    Store in a cool place 8° - 15°C (46° - 59°F) or refrigerate.

  • Keep this and all drugs out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

  • Warnings

    CHILDREN AND TEENAGERS WHO HAVE OR ARE RECOVERING FROM CHICKEN POX, FLU SYMPTOMS, OR FLU SHOULD NOT USE THIS PRODUCT. IF NAUSEA, VOMITING, OR FEVER OCCUR, CONSULT A DOCTOR BECAUSE THESE SYMPTOMS COULD BE AN EARLY SIGN OF REYE SYNDROME, A RARE BUT SERIOUS ILLNESS.

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. 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.

  • ALCOHOL WARNING:

    If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

    Manufactured by Padagis

    Minneapolis, MN 55427

    Rev 04-22

  • Package/Label Principal Display Panel – 300 mg

    NDC 0574-7034-12

    Aspirin Suppositories, USP

    300 mg (5 grains)

    For relief of pain and reduction of fever

    UNIT DOSE

    12 Suppositories

    carton 300mg
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0574-7034
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN300 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0574-7034-1212 in 1 CARTON09/01/1990
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other09/01/1990
    Labeler - Padagis US LLC (967694121)