FDA.reportPublic FDA data

CVS Health Stomach Relief SOFTGEL

Manufacturer
CVS Pharmacy, Inc.
Effective date
2025-01-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:44

Label at a glance#

ProductCVS Health Stomach Relief SOFTGEL
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

relieves • travelers' diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including:   • heartburn • indigestion • nausea • gas • belching • fullness

Dosage and administration

• 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 • dr...

Storage and handling

• each softgel contains: salicylate 102 mg • store at room temperature between 20-25°C (68-77°F) • protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves
• travelers' diarrhea • diarrhea
• upset stomach due to overindulgence in food and drink, including:
  • heartburn • indigestion • nausea • gas • belching • fullness

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other information

STORAGE AND HANDLING SECTION

• 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 INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-800-SHOP-CVS

SPL UNCLASSIFIED SECTION

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™.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stomach ReliefStomach Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121072bismuth subsalicylate 262 MG Oral CapsulePSN2
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-829-22CVS Health Stomach Relief SOFTGEL1 in 1 CARTONCAPSULE, LIQUID FILLED12
51316-829-22CVS Health Stomach Relief SOFTGEL12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-829CVS HEALTH STOMACH RELIEF SOFTGEL (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC.]2Current NDC, 2 package rows20250129_273013b3-9f79-873d-e063-6394a90a6640.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-82951316-829-22

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
YELLOW WAX2ZA36H0S2VIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LIGHT MINERAL OILN6K5787QVPIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
SOYBEAN LECITHIN1DI56QDM62IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Stomach Relief SOFTGELBISMUTH SUBSALICYLATECVS Pharmacy, Inc.273013b3-9f79-873d-e063-6394a90a66402025-01-24WarningsExact identifier
ndc (package): 51316-829-22
ndc (product): 51316-829
ndc11 (package): 51316082922
spl id: 1acdc9c4-88e5-4165-86a9-a37ba0edeb16
spl set id: 273013b3-9f79-873d-e063-6394a90a6640

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.