ASPIRIN suppository

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

Available from:

Padagis US LLC

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 300 mg

Administration route:

RECTAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

ASPIRIN- ASPIRIN SUPPOSITORY
PADAGIS US LLC
_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._
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PERRIGO ASPIRIN SUPPOSITORIES, USP DRUG FACTS
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®
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