ASPIRIN- aspirin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 81 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain Reliever -temporarily relieves minor aches and pains -for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Authorization status:

OTC monograph final

Summary of Product characteristics

ASPIRIN- ASPIRIN TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
_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 EC 81 MG
ACTIVE INGREDIENT(S)
Aspirin 81mg (NSAID*)
*nonsteroidal anti-inflammatory drug
PURPOS E
Pain Reliever
US ES
-temporarily relieves minor aches and pains
-for other uses, see your doctor, but do not use for more than 10 days
without consulting your doctor
because serious side effects may occur.
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
• 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
• you have lost a lot of fluid due to vomiting or diarrhea
ASK A DOCTOR OR PHARMACIST BEFOR