aspirin by Padagis US LLC ASPIRIN suppository

aspirin by

Drug Labeling and Warnings

aspirin by is a Otc medication manufactured, distributed, or labeled by Padagis US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0574-7034
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	300 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0574-7034-12	12 in 1 CARTON	09/01/1990
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/01/1990

ASPIRIN 
aspirin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0574-7036
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	600 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0574-7036-12	12 in 1 CARTON	09/01/1990
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/01/1990

Labeler - Paddock Laboratories, LLC (967694121)