ADULTS LOW STRENGTH ASPIRIN- aspirin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Genvion Corporation

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever - temporarily relieves minor aches and pains - Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief

Authorization status:

OTC monograph not final

Summary of Product characteristics

ADULTS LOW STRENGTH ASPIRIN- ASPIRIN TABLET
GENVION CORPORATION
_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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ADULT'S LOW STRENGTH ASPIRIN
DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Aspirin 81mg (NSAID*)
*nonsteroidal anti-inflammatory drug
PURPOS E
Pain reliever
US ES
temporarily relieves minor aches and pains
Because of its delayed action, this product will not provide fast
relief of headaches, fever, or other
symptoms needing immediate relief
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
asthma (wheezing)
shock
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
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
you experience any of the foll