Stomach Relief

Manufacturer
CVS PHARMACY | LNK International, Inc.
Effective date
2021-11-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:28:42

Label at a glance#

ProductStomach Relief Ultra
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Indications and uses

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

Dosage and administration

drink plenty of clear fluids to help prevent dehydration caused by diarrhea swallow with water; do not chew adults and children 12 years and over: 1 caplet every 1/2 to 1 hour as needed. Do not exceed 8 caplets in 24 hours. do not use for more than 2 days unless directed by a doctor use until diarrhea stops, but not more than 2 days children under 12 years: ask a doctor 

Storage and handling

each caplet contains:  calcium 45 mg, salicylate 206 mg, sodium 3 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive heat see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient ( in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

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

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 chances 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

OTC - DO NOT USE SECTION

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

  • anticoagulation (thinning the blood)
  • gout
  • diabetes
  • arthritis 

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • swallow with water; do not chew
  • adults and children 12 years and over: 1 caplet every 1/2 to 1 hour as needed. Do not exceed 8 caplets in 24 hours.
  • do not use for more than 2 days unless directed by a doctor
  • use until diarrhea stops, but not more than 2 days
  • children under 12 years: ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 45 mg, salicylate 206 mg, sodium 3 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose,
povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥︎CVS 
Health®

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

ULTRA
Stomach
Relief

BISMUTH SUBSALICYLATE
525 mg
Upset stomach reliever/
Antidiarrheal

Soothing relief for 5 symptoms:

  • Heartburn
  • Indigestion
  • Upset stomach
  • Nausea
  • Diarrhea

Actual Size

24 CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Pepto-Bismol® Ultra.
50844     ORG121974908

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2021 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-14236
CVS Quality
Money Back Guarantee

CVS Health 44-749
CVS Health 44-749

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-47969842-479-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
0d22a055-c4f7-4316-85a3-e9c8e77f1dbc73801441-13a4-4e06-ab6f-aa5fa2d13b282021-11-09WarningsExact identifier
spl id: 0d22a055-c4f7-4316-85a3-e9c8e77f1dbc
spl set id: 73801441-13a4-4e06-ab6f-aa5fa2d13b28

Reported adverse events (FAERS/openFDA)#

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