Country: United States
Language: English
Source: NLM (National Library of Medicine)
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Spirit Pharmaceuticals LLC
ORAL
OTC DRUG
Upset stomach reliever and anti-diarrheal relieves • travelers’ diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching • fullness • an ulcer • a bleeding problem • bloody or black stool • fever • mucus in the stool you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis
OTC monograph final
STOMACH RELIEF- BISMUTH SUBSALICYLATE CAPSULE, LIQUID FILLED SPIRIT PHARMACEUTICALS LLC ---------- STOMACH RELIEF _DRUG FACTS_ _ACTIVE INGREDIENT (IN EACH TABLET)_ Bismuth subsalicylate 262 mg _PURPOSE_ Upset stomach reliever and anti-diarrheal _USES_ relieves • travelers’ diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching • fullness _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 • allergic to salicylates (including aspirin) • taking other salicylate products DO NOT USE IF YOU HAVE • an ulcer • a bleeding problem • bloody or black stool ASK A DOCTOR BEFORE USE IF YOU HAVE • fever • mucus in the stool ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE IF YOU ARE you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis WHEN USING THIS PRODUCT • 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 CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. (1- 800-222-1222) _DIRECTIONS_ • swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 softgels) in 24 hours • use until diarrhea stops but not more than 2 days • children under 12 years Read the complete document