Country: United States
Language: English
Source: NLM (National Library of Medicine)
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Novartis Consumer Health, Inc.
ORAL
OTC DRUG
Pain reliever - temporarily relieves minor aches and pains or as recommended by your doctor - ask your doctor about other uses of buffered aspirin 81 mg - if you have ever had an allergic reaction 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 are taking a diuretic - you are on a magnesium-restricted diet - you have asthma - any other drug containing an NSAID (prescription or nonprescription) - a blood thinning (anticoagulant) or steroid drug - a prescription drug for diabetes, gout, or arthritis - any other drug, or are under a doctor’s care for any serious condition - an allergic reaction occurs. Seek medical help right away. - 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 - fee
OTC monograph final
BUFFERIN LOW DOSE BUFFERED ASPIRIN- ASPIRIN TABLET NOVARTIS CONSUMER HEALTH, INC. _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._ ---------- DRUG FACTS ACTIVE INGREDIENT _(IN EACH TABLET)_ Buffered aspirin equal to 81 mg aspirin (NSAID)* (buffered with calcium carbonate, magnesium carbonate and magnesium oxide) *nonsteroidal anti-inflammatory drug PURPOS E Pain reliever US ES temporarily relieves minor aches and pains or as recommended by your doctor ask your doctor about other uses of buffered aspirin 81 mg WARNINGS 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 • asthma (wheezing) • shock 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 DO NOT USE if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer ASK A DOCTOR BEFORE USE IF 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 are taking a diuretic you are on a magnesium-restricted diet you have asthma ASK DOCTOR OR PHARMACIST BEFORE USE I Read the complete document