Active Ingredient (In Each Tablet)
Buffered aspirin equal to
325 mg aspirin (NSAID)*
(buffered with magnesium carbonate, calcium carbonate
and magnesium oxide)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Tri-buffered Aspirin (NDC 0904-2015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
if you are allergic to aspirin or any other pain reliever/fever reducer.
taking a prescription drug for
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 (1-800-222-1222) 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
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
(800) 616-2471
MAJOR®
NDC 0904-2015-59
†Compare to the active
ingredient in BUFFERIN®
TRI-BUFFERED
ASPIRIN
325 mg
pain reliever/fever reducer (NSAID)
100 TABLETS
†This product is not manufactured or distributed by Ducere Pharma, owner of the registered trademark Bufferin®.
50844 REV1214L18312
Distributed by MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150 USA M-17
Re-Order No. 700594 Rev. 01/15
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
* Please review the disclaimer below.