Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameBISMUTH SUBSALICYLATE
Labeler / manufacturerH E B
RouteORAL
Drug classBismuth
Product NDC37808-346
Label effective date2026-08-21
Official product label reference
Stomach Relief — H E B
This page contains 15 source sections for BISMUTH SUBSALICYLATE, oral route. Label set 7d721ce3-746f-49aa-916d-eb5a8b357813, version 15.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses relieves: travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
Purpose
Purpose Upset stomach reliever/antidiarrheal
Dosage and administration — label text
Directions do not take more than directed swallow with water; do not chew drink plenty of clear fluids to help prevent dehydration caused by diarrhea adults and children 12 years and over: 2 caplets every ½ to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours. do not use for more than 2 days unless directed by a doctor use until diarrhea stops, but not more than 2 days children under 12 years: ask a doctor
Warnings
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) gout diabetes arthritis 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 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.
Active ingredient
Active ingredient (in each caplet) Bismuth subsalicylate 262 mg
Do not use
Do not use if you have an ulcer a bleeding problem bloody or black stool
Ask a doctor before use
Ask a doctor before use if you have fever mucus in the stool
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) gout diabetes arthritis
While using this medicine
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.
When to stop use and seek help
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
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage and handling
Other information each caplet contains: calcium 20 mg, salicylate 103 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive heat see end flap for expiration date and lot number
Inactive ingredient
Inactive ingredients calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.