FDA Label for Upset Stomach Relief-bismuth Subsalicylate 262 Mg

View Indications, Usage & Precautions

Upset Stomach Relief-bismuth Subsalicylate 262 Mg Product Label

The following document was submitted to the FDA by the labeler of this product Nuvicare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Softgel)



Bismuth subsalicylate 262 mg


Purpose



Upset stomach reliever and antidiarrheal


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


Directions



■ swallow with water, do not chew
■ adults and children 12 years and over:
■ 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
■ 2 softgels every ½ hour to 1 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: ask a doctor
■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea


Other Information



■ each softgel contains:
■ salicylate 99 mg
■ low sodium
■ do not exceed 25°C


Inactive Ingredients



Polyethylene Glycol-400, Polysorbate 80, Soya Lecithin, Povidone (PVPK 30), Gelatin, Glycerin, Sorbitol Sorbitan Solution, D & C Red 33 , Titanium Dioxide, Purified Water


Questions Or Comments?



Call 1 (718) 337-8733 or email: [email protected]


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