BISMUTH SUBSALICYLATE tablet, film coated

Bismuth Subsalicylate by

Drug Labeling and Warnings

Bismuth Subsalicylate by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

PURPOSE

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 dyas. 
• 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 immediately.

Directions

• swallow caplets with water, do not chew 
• adults and children 12 years and over: 2 caplets (1 dose) every 1/2 to 4 cpalets (2 doses) every hour as needed for diarrhea
• 2 cpaltes (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) 
• do not exceed 8 doses (16 caplets) 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 caplet contains: salicylate 102 mg 
• store at room temperature, in a dry place 
• TAMPER EVIDENT: do not use if printed seal under cap is torn or missing

INACTIVE INGREDIENT

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.

Questions or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

RETAIN CARTON FOR FULL LABELING INFORMATION

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2019 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-30287

PRINCIPAL DISPLAY PANEL

CVSHealth

Compare to the active ingredient in Pepto-Bismol® Caplets*

Stomach Relief

DYE FREE

Bismuth Subsalicylate 262mg

Upset stomach reliever/Antidiarrheal

Soothing relief for 5 symptoms:

Heartburn

Indigestion

Upset stomach

Nausea

Diarrhea

Package Contains One Bottle

40 Caplets

INGREDIENTS AND APPEARANCE

BISMUTH SUBSALICYLATE 
bismuth subsalicylate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-346
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIACETIN (UNII: XHX3C3X673)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	V
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-346-28	1 in 1 CARTON	07/06/2018
1		40 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69842-346-12	1 in 1 CARTON	07/06/2018
2		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	07/06/2018

Labeler - CVS Pharmacy, Inc. (062312574)