Active Ingredient (In Each 15 Ml Dose)
Bismuth subsalicylate 262 mg
Bismuth Subsalicylate Liquid
FDA Label NDC 81033-046
17 label sections · Submitted to the FDA by Kesin Pharma · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma for the product Bismuth Subsalicylate (NDC 81033-046). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 15 ml dose), purpose, uses, warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Upset stomach reliever and antidiarrheal
Uses
- relieves
- travelers’ diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartbun
- 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 taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- shake well before use
- adults and children 12 years and over:
- 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for
- diarrhea/traveler’s diarrhea
- 30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach,
- heartburn, indigestion, nausea)
- do not exceed 8 doses (240 mL) in 24 hours
- use until diarrhea stops but no 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 15 mL dose contains: sodium 11 mg
- salicylate 125 mg
- protect from freezing
- avoid excessive heat (over 104°F or 40°C)
- Bismuth subsalicylate is a pink liquid with mint odor and available in the following:
NDC 81033-046-15: 15 mL unit-dose cup
NDC 81033-046-34: Carton containing 30 unit-dose cups of 15 mL each
Inactive Ingredients
anhydrous citric acid, benzoic acid, D&C Red #22, D&C Red #28, flavor, purified water, salicylic acid, sodium citrate, sodium
salicylate, sorbic acid, sucralose, xanthan gum.
Questions Or Comments
Call 1-833-537-4679
Other
*This product is not manufactured or distributed by The Procter and Gamble Company. Pepto-Bismol® is a registered
trademark of The Procter and Gamble Company.
Distributed by:
Kesin Pharma
Oldsmar, FL 34677
PIS-046-V01
Rev. 08/2026
Package Label.Principal Display Panel
NDC: 81033-046-34
Bismuth Subsalicylate Liquid
262 mg per 15 mL
Delivers 15 mL
30 x 15 mL Unit Dose Cups
Bismuth Carton 30 Ct (Bismuth 15ml Carton 30ct)
* Please review the disclaimer below.
