ASPIRIN- aspirin tablet, delayed release

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

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download SPC (SPC)
26-12-2012

active_ingredient:

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

MAH:

AAA Pharmaceutical, Inc.

INN:

ASPIRIN

composition:

ASPIRIN 325 mg

administration_route:

ORAL

prescription_type:

OTC DRUG

therapeutic_indication:

Pain reliever - for the temporary relief of minor aches and pains due to: headache muscle pain toothache menstrual pain colds minor pain of arthritis - headache - muscle pain - toothache - menstrual pain - colds - minor pain of arthritis - or as recommended by your doctor

authorization_status:

OTC monograph not final

SPC

                                ASPIRIN- ASPIRIN TABLET, DELAYED RELEASE
AAA PHARMACEUTICAL, 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._
----------
ASPIRIN TABLETS
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET)
Aspirin 325 mg (NSAID )
1
PURPOS E
Pain reliever
US ES
for the temporary relief of minor aches and pains due to:
headache
muscle pain
toothache
menstrual pain
colds
minor pain of arthritis
or as recommended 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 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
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
1
nonsteroidal anti-inflammatory drug
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 more alcoholic drinks every day while using this product
take more or for a longer time than directed
DO NOT USE if you have ever had an allergic reaction to 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
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking a prescription
drug for:
diabetes
gout
arthritis
STOP USE AND ASK A DOCTOR IF
an allergic reaction occurs. Seek medical h
                                
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