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Drug Facts
Distributed by:
Genomma Lab USA Inc.
Houston, TX 77027
The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Bufferin Regular Strength Pain Relief (NDC 50066-610). 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 other, active ingredient (in each tablet), purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by:
Genomma Lab USA Inc.
Houston, TX 77027
Buffered aspirin equal to 325 mg aspirin (NSAID)
nonsteroidal anti-inflammatory drug
(buffered with calcium carbonate, magnesium carbonate, and magnesium oxide)Pain reliever/fever reducer
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.
Aspirin may cause a severe allergic reaction, which may include:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Ask a doctor or pharmacist before use if you are taking a prescription drug for
These could be signs of a serious condition.
If pregnant or breast-feeding, 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
anhydrous citric acid, corn starch, dibasic sodium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide
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