BUFFERIN REGULAR STRENGTH PAIN RELIEF- aspirin tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E)

Available from:

Genomma Lab USA

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer - temporarily relieves minor aches and pains associated with: headache toothache backache muscular aches headache minor pain of arthritis the common cold premenstrual & menstrual cramps - headache - toothache - backache - muscular aches - headache - minor pain of arthritis - the common cold - premenstrual & menstrual cramps - temporarily reduces fever

Authorization status:

OTC monograph not final

Summary of Product characteristics

BUFFERIN REGULAR STRENGTH PAIN RELIEF- ASPIRIN TABLET, COATED
GENOMMA LAB USA
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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BUFFERIN REGULAR STRENGTH PAIN RELIEF
DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Buffered aspirin equal to 325 mg aspirin (NSAID) (buffered with
calcium carbonate,
magnesium carbonate, and magnesium oxide)
1
PURPOSE
Pain reliever/fever reducer
USES
temporarily relieves minor aches and pains associated with:
headache
toothache
backache
muscular aches
headache
minor pain of arthritis
the common cold
premenstrual & menstrual cramps
temporarily reduces fever
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
®
1
nonsteroidal anti-inflammatory drug
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
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
are age 60 or older
have 3 or more alcoholic drinks every day while using this product
take other drugs containing prescription or nonprescription NSAIDs
[aspirin,
ibuprofen, naproxen, or others]
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
if you have ever had an allergic reaction to this product or any of
its ingredients
ASK A DOCTOR BEFORE USE IF
stomach bleeding warning applies to you
you have asthma
you have a history of stomach problems, such as heartburn
you are taking a diu