TRI-BUFFERED ASPIRIN
-
aspirin tablet, film coated
Major Pharmaceuticals
Buffered aspirin equal to 325 mg aspirin (NSAID)*.
(buffered with magnesium carbonate, calcium carbonate and magnesium oxide)
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily relieves minor aches and pains associated with:
muscular aches backache
headache
minor pain of arthritis
backache
toothache
the common cold
premenstrual & menstrual cramps
temporarily reduces fever
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
if you are allergic to aspirin or any other pain reliever/fever reducer
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 have asthma
you are taking a diuretic
taking a prescription drug for
gout
diabetes
arthritis
you experience any of the following signs of stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
an allergic reaction occurs
symptoms do not improve
new symptoms occur
ringing in the ears or loss of hearing occurs
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
These could be signs of a serious condition.
ask a health professional before use. It is especially important not to use aspirin 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.
In case of overdose, get medical help or contact a Poison Control Center right away.
adults and children 12 years and over: 2 tablets with a full glass of water. Dosage may be repeated every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless directed by a doctor.
children under 12 years: do not use unless directed by a doctor
each tablet contains: calcium 35 mg and magnesium 40 mg
store at controlled room temperature 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
citric acid, corn starch, dibasic sodium phosphate, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide
To Report Adverse Drug Event Call: 1-800-426-9391
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
MAJOR®
See New Warnings Information
NDC 0904-2015-59
TRI-BUFFERED
ASPIRIN
PAIN RELIEF
pain reliever/fever reducer (NSAID)
100 TABLETS • 325 mg
Compare to the active ingredient in BUFFERIN®
Distributed by MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150 USA M-17
Re-Order No. 700594 Rev. 11/10
TAMPER EVIDENT: DO NO USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV1110H18312
TRI-BUFFERED ASPIRIN
aspirin tablet, film coated | ||||||||||||||||||||
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC MONOGRAPH NOT FINAL | part343 | 03/30/1990 |
Labeler - Major Pharmaceuticals (191427277) |