Label: ASPIRIN suppository

  • NDC Code(s): 0574-7034-12, 0574-7036-12
  • Packager: Paddock Laboratories, LLC
  • 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 July 2, 2019

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

  • Active ingredient

    Aspirin Suppositories, USP 300 mg (5 grains)

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

    OR

    Aspirin Suppositories, USP 600 mg (10 grains)

    Each suppository contains 600 mg (10 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 Perrigo®

    Minneapolis, MN 55427

    Rev 05-19 B

  • 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

    aspirin-300mg.JPG
  • Package/Label Principal Display Panel – 600 mg

    NDC 0574-7036-12

    Aspirin Suppositories, USP

    600 mg (10 grains)

    For relief of pain and reduction of fever

    UNIT DOSE

    12 Suppositories

    aspirin-600mg.JPG
  • 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
    OTC monograph not finalpart34309/01/1990
    ASPIRIN 
    aspirin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0574-7036
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN600 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:0574-7036-1212 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
    OTC monograph not finalpart34309/01/1990
    Labeler - Paddock Laboratories, LLC (967694121)