ADULT LOW DOSE- aspirin 81 mg tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Safrel Pharmaceuticals, LLC.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. - ask your doctor about other uses for 81 mg Aspirin

Authorization status:

OTC monograph final

Summary of Product characteristics

ADULT LOW DOSE- ASPIRIN 81 MG TABLET, DELAYED RELEASE
SAFREL PHARMACEUTICALS, 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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ASPIRIN 81 MG ENTERIC COATED TABLETS
_DRUG FACTS_
ACTIVE INGREDIENTS (IN EACH TABLET) PURPOSE
Aspirin 81 mg (NSAID)* ........................................ Pain
reliever
*nonsteroidal anti-inflammatory drug
USES
temporary relief of minor aches and pains or as recommended by your
doctor.
BECAUSE OF ITS DELAYED ACTION, THIS PRODUCT WILL NOT PROVIDE FAST
RELIEF OF
HEADACHES OR OTHER SYMPTOMS NEEDING IMMEDIATE RELIEF.
ask your doctor about other uses for 81 mg Aspirin
WARNINGS
REYE'S SYNDROME
Children and teenagers who have or are recovering from chicken pox or
flu-like
symptoms should not use this product. When using this product, if
changes in behavior
with nausea and vomiting occur, consult a doctor because these
symptoms could be an
early sign of Reye's syndrome, a rare but serious illness.
ALLERGY ALERT
Aspirin may cause a severe allergic reaction which may include:
hives
shock
facial swelling
asthma (wheezing)
STOMACH BLEEDING WARNING
This product contains an NSAID, which may cause severe stomach
bleeding. The
chance is higher if you:
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs
[aspirin,
ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
DO NOT USE
if you are allergic to aspirin or any other pain reliever/fever
reducer
ASK A DOCTOR BEFORE USE IF
you have asthma
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis or kidney
disease
you are taking a diuretic
ASK A DOCTOR OR PHAR