Bismuth Subsalicylate by MEIJER DISTRIBUTION, INC. Stomach Relief

Bismuth Subsalicylate by

Drug Labeling and Warnings

Bismuth Subsalicylate by is a Otc medication manufactured, distributed, or labeled by MEIJER DISTRIBUTION, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BISMUTH SUBSALICYLATE- bismuth subsalicylate capsule, liquid filled 
MEIJER DISTRIBUTION, INC.

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Stomach Relief

Drug Facts

Active ingredient (in each softgel)
Bismuth subsalicylate 262 mg

Purpose
Upset stomach reliever and anti-diarrheal

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

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

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

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.

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 102 mg
very low sodium
do not exceed 25°C

Inactive ingredients
aerosil, beeswax, D&C Red#33, gelatin, glycerin, light liquid paraffin,
povidone, purified water, sodium carboxy methyl cellulose, sorbitol
sorbitan solution, soya lecithin, titanium dioxide

Questions or comments? 1-888-333-9792

Stomach Relief

BISMUTH SUBSALICYLATE 262 mg
Upset stomach reliever/Antidiarrheal

Soothing relief for 5 symptoms:
Heartburn
Indigestion
Upset stomach

Nausea

BISMUTH SUBSALICYLATE 
bismuth subsalicylate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-0056
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	854
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79481-0056-2	2 in 1 CARTON	01/22/2024
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	01/22/2024	02/01/2024

Labeler - MEIJER DISTRIBUTION, INC. (006959555)

Revised: 12/2024

Document Id: 29badfc9-38e4-f310-e063-6294a90a8790

34390-5

Set id: 69ee3cf9-b31b-4a02-8fef-dea31ec27506

Version: 3

Effective Time: 20241220