Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)
First Aid Direct
ORAL
OTC DRUG
Antidiarrheal/Antacid relieves - travelers’ diarrhea - diarrhea - upset stomach due to overindulgence in food and drink including: - heartburn - indigestion - nausea - gas - belching - fullness
OTC monograph final
PEP TUM- BISMUTH SUBSALICYLATE TABLET, CHEWABLE FIRST AID DIRECT _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) Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate) PURPOS E Antidiarrheal/Antacid US ES controls diarrhea relieves heartburn, indigestion, nausea and upset stomach without constipating 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 bloody or black stool an ulcer a bleeding problem ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis STOP USE AND ASK A DOCTOR IF symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days WHEN USING THIS PRODUCT a temporary, but harmless, darkening of the stool and/or tongue may occur. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, contact a doctor or Poison Control Center immediately. DIRECTIONS drink plenty of clear fluids to help prevent dehydration caused by diarrhea ADULTS AND CHILDREN 12 YEARS AND OVER: 525 mg (2 tablets) every ½ to 1 hour or 1050 mg (4 tablets) every hour as needed do not exceed 4200 mg ( 16 tablets) in 24 hours use until diarrhea stops but not more than 2 days CHILDREN UNDER 12 YEARS: ask a doctor INACTIVE INGREDIENTS aspartame, calcium carbonate, , D&C red #27, dextrates, flavor Læs hele dokumentet