REGULAR STRENGTH ASPIRIN EC- aspirin tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- for the temporary relief of minor aches and pains due to - headache colds muscle pain menstrual pain toothache minor pain of arthritis - headache - colds - muscle pain - menstrual pain - toothache - minor pain of arthritis - or as directed by your doctor - if you are allergic to aspirin or any other pain reliever/fever reducer - 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 - feel faint - have bloody or black stools - vomit blood - have stomach pain that does not get better - pain gets worse or lasts more than 10 days - fever gets worse or lasts more than 3 days - redness or swelling is present in the painful area - any new symptoms appear - ringing in the ears or a loss of hearing occurs

Authorization status:

OTC monograph final

Summary of Product characteristics

REGULAR STRENGTH ASPIRIN EC - ASPIRIN TABLET, DELAYED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, 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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DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET) PURPOSE
Aspirin 325 mg (NSAID*).............................Pain reliever
*nonsteroidal anti-inflammatory drug
PURPOS E
Pain reliever
US ES
for the temporary relief of minor aches and pains due to
headache
colds
muscle pain
menstrual pain
toothache
minor pain of arthritis
or as directed by your doctor
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 or 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 inclue:
hives
facial swelling
shock
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 are taking a diuretic
you have asthma
you have not been drinking fluids
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking a prescription drug for diabete