Tri-Buffered Aspirin
Dosage form: tablet, film coated
Ingredients: ASPIRIN 325mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-2015
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.
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
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temporarily relieves minor aches and pains associated with:
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muscular aches backache
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headache
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minor pain of arthritis
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backache
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toothache
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the common cold
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premenstrual & menstrual cramps
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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:
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hives
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facial swelling
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shock
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asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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are age 60 or older
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have had stomach ulcers or bleeding problems
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take a blood thinning (anticoagulant) or steroid drug
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take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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have 3 or more alcoholic drinks every day while using this product
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take more or for a longer time than directed
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if you are allergic to aspirin or any other pain reliever/fever reducer
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stomach bleeding warning applies to you
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you have a history of stomach problems, such as heartburn
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you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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you have asthma
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you are taking a diuretic
taking a prescription drug for
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gout
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diabetes
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arthritis
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you experience any of the following signs of stomach bleeding:
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feel faint
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vomit blood
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have bloody or black stools
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have stomach pain that does not get better
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an allergic reaction occurs
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symptoms do not improve
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new symptoms occur
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ringing in the ears or loss of hearing occurs
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pain gets worse or lasts more than 10 days
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fever gets worse or lasts more than 3 days
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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.
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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.
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children under 12 years: do not use unless directed by a doctor
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each tablet contains: calcium 35 mg and magnesium 40 mg
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store at controlled room temperature 15°-30°C (59°-86°F)
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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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| Labeler - Major Pharmaceuticals (191427277) |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
