Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Topco Associates, LLC
ORAL
OTC DRUG
Upset stomach reliever and anti-diarrheal relieves: - indigestion - nausea - heartburn - diarrhea - upset stomach associated with these symptoms - bloody or black stool - an ulcer - a bleeding problem - fever - mucus in the stool taking any drug for - anticoagulation (thinning of the blood) - diabetes - gout - arthritis - symptoms get worse - ringing in the ears or loss of hearing occurs - diarrhea lasts more than 2 days
OTC monograph final
TOPCO STOMACH RELIEF - BISMUTH SUBSALICYLATE TABLET TOPCO ASSOCIATES, LLC _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._ ---------- TOPCO STOMACH RELIEF CAPLETS ACTIVE INGREDIENT(IN EACH CAPLET) Bismuth subsalicylate 262 mg PURPOSE Upset stomach reliever and anti-diarrheal USE(S) relieves: indigestion nausea heartburn diarrhea upset stomach associated with these symptoms 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 behaviour 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: CONTAINS SALICYLATE. DO NOT TAKE IF YOU ARE allergic to salicylates (including aspirin) taking other salicylate products DO NOT USE IF YOU HAVE bloody or black stool an ulcer a bleeding problem ASK A DOCTOR BEFORE USE IF YOU HAVE fever mucus in the stool ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis WHEN USING THIS PRODUCT a temporary, but harmless darkening of the stool and/or tongue may occur STOP USE AND ASK DOCTOR IF symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away. DIRECTIONS swallow caplet(s) with water, do not chew adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed do not take more than 8 doses (16 tablets) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea OTHER INFORMATION Baca dokumen lengkapnya