BISMUTH SUBSALICYLATE- bismuth subsalicylate capsule, gelatin coated
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.
Active ingredient ( in each softgel) Purpose
Bismuth subsalicylate 262 mg …………….Upset stomach reliever and anti-diarrheal
- travelers’ diarrhea
- upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching
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.
- allergic to salicylates (including aspirin)
- taking other salicylate products
- an ulcer
- a bleeding problem
- bloody or black stool
- mucus in the stool
taking any drug for
- anticoagulation (thinning the blood)
- a temporary, but harmless, darkening of the stool and/or tongue may occur
- 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.
- 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
- 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
- each softgel contains: salicylate 102.33 mg
- very low sodium
- do not exceed 25°C
aerosil, beeswax, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide
BISMUTH SUBSALICYLATE 262 mg
Upset stomach reliever/Antidiarrheal
Soothing relief for 5 symptoms:
• Upset stomach
| BISMUTH SUBSALICYLATE |
bismuth subsalicylate capsule, gelatin coated
|Labeler — TOPCO ASSOCIATES LLC (006935977)|
Revised: 09/2021 TOPCO ASSOCIATES LLC
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.