ASPIRIN- aspirin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health, Inc.

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever temporarily relieves - headache - muscle pain - toothache - menstrual pain - pain and fever of colds - minor pain of arthritis Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. Stop use and ask a doctor if - an allergic reaction occurs. Seek medical help right away. - you experience any of the following signs of stomach bleeding: •feel faint •have bloody or black stools •vomit blood •have stomach pain that does not get better - new symptoms occur - pain gets worse or lasts more than 10 days - redness or swelling is present - fever lasts more than 3 days - ringing in the ears or a loss of hearing occurs

Authorization status:

OTC monograph final

Summary of Product characteristics

ASPIRIN- ASPIRIN TABLET, FILM COATED
CARDINAL HEALTH, INC.
_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 ENTERIC COATED TABLETS, 325 MG
_ACTIVE INGREDIENT (IN EACH TABLET)_
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
_PURPOSE_
Pain reliever
_USES_
temporarily relieves
headache
muscle pain
toothache
menstrual pain
pain and fever of colds
minor pain of arthritis
_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
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 have asthma
you are taking a diuretic
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking a prescription
drug for
gout
diabetes
arthritis
STOP USE AND ASK A DOCTOR IF
an allergic reaction occurs. Seek medical help right away.
you experience any of the follow