BISMUTH SUBSALICYLATE capsule, gelatin coated

Bismuth Subsalicylate by

Drug Labeling and Warnings

Bismuth Subsalicylate by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient ( in each softgel)                        Purpose

Bismuth subsalicylate 262 mg ................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

beeswax, collidal silicon dioxide, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, povidone, purified water, soya lecithin, sodium carboxymethyl cellulose, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

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PRINCIPAL DISPLAY PANEL

Stomach relief

Bismuth Subsalicylate 262 mg
Upset Stomach Reliever/Antidiarrheal

Soothing relief for 5 symptoms:
Heartburn Indigestion Upset stomach
Nausea Diarrhea

12 Softgels

INGREDIENTS AND APPEARANCE

BISMUTH SUBSALICYLATE 
bismuth subsalicylate capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-5018
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
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POVIDONE (UNII: FZ989GH94E)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL (Oblong shaped)	Size	21mm
Flavor		Imprint Code	262
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-5018-1	1 in 1 CARTON	07/19/2023
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	07/19/2023

Labeler - Spirit Pharmaceuticals LLC (179621011)