Country: United States
Language: English
Source: NLM (National Library of Medicine)
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385
ORAL
OTC DRUG
Upset stomach reliever/Antidiarrheal relieves - upset stomach - heartburn - indigestion - diarrhea - nausea
OTC monograph final
STOMACH RELIEF ORIGINAL STRENGTH- BISMUTH SUBSALICYLATE LIQUID AMERISOURCEBERGEN DRUG CORPORATION (GOOD NEIGHBOR PHARMACY) 24385 _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 15 ML, 1 TABLESPOON) Bismuth subsalicylate 262 mg PURPOS E Upset stomach reliever/Antidiarrheal US ES relieves upset stomach heartburn indigestion diarrhea nausea 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: Contains salicylate Do not take if you are: taking other salicylate products allergic to salicylates (including aspirin) DO NOT USE IF YOU HAVE an ulcer a bleeding problem bloody or black stool ASK A DOCTOR BEFORE USE IF YOU HAVE a sodium-restricted diet fever mucus in the stool ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking any drug for diabetes gout arthritis anticoagulation (thinning the blood) WHEN USING THIS PRODUCT a temporary, but harmless, darkening of the stool and/or tongue may occur. STOP USE AND ASK A DOCTOR IF symptoms get worse or last more than 2 days 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 CHILDEN. In case of overdose, get medical help or contact a Posion Control Center right away. (1-800-222-1222) DIRECTIONS shake well before using mL = milliliter; TBSP = tablespoon use the enclosed dosing cup designed for use with this product, or tablespoon (TBSP) adults and children 12 years and over 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed do not exceed 8 doses (240 mL or 16 TBSP) Read the complete document