Adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids. Children under 12 years: ask a doctor. Do not use for more than a 3 day period unless directed by a doctor.
Storage and handling
each tablet contains: sodium 24.4 mg store at 59-86°F (15-30°C) in a cool dry place protect from sunlight
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.
Stomach bleeding warning:This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you
are 60 or older
have stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing an NSAID (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
OTC - DO NOT USE SECTION
if you are allergic to salicylates (including aspirin)
Ask a doctor before use if you have
OTC - ASK DOCTOR SECTION
frequent, burning urination for the first time
the stomach bleeding warning applying to you
history of stomach problems, such as heartburn
high blood pressure
heart disease
liver cirrhosis
bleeding problems
diuretic use
ulcers
kidney disease
a sodium restricted diet
reach age 60 or older
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
taking any other drug containing an NSAID (prescription or non-prescription)
taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug
When using this product
OTC - WHEN USING SECTION
do not take more than the recommended dosage
Stop use and ask a doctor if
OTC - STOP USE SECTION
product has been used for 3 days
ringing in the ears
you experience any of the following signs of stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have stomach pain or upset that gets worse or lasts
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding ask a health professional before use. It is especially important not to use this product (which contains sodium salicylate) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.
Directions
DOSAGE & ADMINISTRATION SECTION
Adults and children 12 years and over:
take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids.
Children under 12 years:
ask a doctor.
Do not use for more than a 3 day period unless directed by a doctor.
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.
Stomach Bleeding Warning:This
product contains a nonsteroidal anti-inflammatory drug (NSAID), which
may cause stomach bleeding. The chance is higher if you: ■ are age 60 or
older ■ have stomach ulcers or bleeding problems ■ take a blood thinner
(anticoagulant) or steroid drug ■ take other drugs containing an NSAID
(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.
ATTENTION: USE ONLY IF TABLET
BLISTER SEALS ARE UNBROKEN
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.