Cvs 

Cvs 
SPL v2
SPL
SPL Set ID 273013b3-9f79-873d-e063-6394a90a6640
Route
ORAL
Published
Effective Date 2025-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Yellow Wax Silicon Dioxide D&c Red No. 33 Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Light Mineral Oil Povidone, Unspecified Water Carboxymethylcellulose Sodium, Unspecified Sorbitol Sorbitan Soybean Lecithin Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-24

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 262 mg

Uses

relieves

• travelers' diarrhea • diarrhea

• upset stomach due to overindulgence in food and drink, including:

  • heartburn • indigestion • nausea • gas • belching • fullness

Section 42229-5

Compare to the active ingredient in Pepto-Bismol ® Liquicaps™*

Upset stomach reliever/Antidiarrheal

Relieves 5 symptoms

• Nausea

• Heartburn

• Indigestion

• Upset stomach

• Diarrhea

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com®

Product of India   V-39102

100% money back guaranteed.

CVS.com/returnpolicy

*This product is not manufactured or distributed by The Procter & Gamble company, owner of the registered trademarks Pepto-Bismol® Liquicaps™.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Packaging

Directions

• swallow with water, do not chew

• adults and children 12 years and over:

    • 2 softgels every 1/2 hour or 4 softgels every hour as needed for diarrhea

    • 2 softgels every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

    • do not exceed 16 softgels 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

Drug Facts

Other Information

• each softgel contains: salicylate 102 mg

• store at room temperature between 20-25°C (68-77°F)

• protect from light, heat and moisture

Inactive Ingredients

beeswax, colloidal silicon dioxide, D&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, povidone, purified water, sodium carboxy methyl cellulose, sorbitol sorbitan solution, soy lecithin, titanium dioxide

Questions Or Comments?

Call 1-800-SHOP-CVS

Active Ingredient (in Each Softgel)

Bismuth subsalicylate 262 mg


Structured Label Content

Uses

relieves

• travelers' diarrhea • diarrhea

• upset stomach due to overindulgence in food and drink, including:

  • heartburn • indigestion • nausea • gas • belching • fullness

Section 42229-5 (42229-5)

Compare to the active ingredient in Pepto-Bismol ® Liquicaps™*

Upset stomach reliever/Antidiarrheal

Relieves 5 symptoms

• Nausea

• Heartburn

• Indigestion

• Upset stomach

• Diarrhea

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com®

Product of India   V-39102

100% money back guaranteed.

CVS.com/returnpolicy

*This product is not manufactured or distributed by The Procter & Gamble company, owner of the registered trademarks Pepto-Bismol® Liquicaps™.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Upset stomach reliever and antidiarrheal

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.

Packaging

Directions

• swallow with water, do not chew

• adults and children 12 years and over:

    • 2 softgels every 1/2 hour or 4 softgels every hour as needed for diarrhea

    • 2 softgels every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

    • do not exceed 16 softgels 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

Drug Facts

Other Information (Other information)

• each softgel contains: salicylate 102 mg

• store at room temperature between 20-25°C (68-77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

beeswax, colloidal silicon dioxide, D&C Red No. 33, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, povidone, purified water, sodium carboxy methyl cellulose, sorbitol sorbitan solution, soy lecithin, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-SHOP-CVS

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Bismuth subsalicylate 262 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)