ASPIRIN- aspirin suppository 
Padagis US LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Aspirin Suppositories, USP

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
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)

Revised: 4/2022
Document Id: a6ca751c-7438-4a0f-adae-d176f73f4915
Set id: cce244aa-cd79-49c8-b68e-267f2bd0ef67
Version: 6
Effective Time: 20220430
 
Padagis US LLC