STOMACH RELIEF MAXIMUM STRENGTH

Manufacturer
CVS Pharmacy, Inc. | Aurohealth LLC
Effective date
2019-11-30
Label type
Human OTC Drug Label
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:56:04

Label at a glance#

ProductSTOMACH RELIEF MAXIMUM STRENGTH
Active ingredientBISMUTH SUBSALICYLATE
Label structure12 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

shake well before use mL=milliliter use dose cup or tablespoon (TBSP) adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every hour as needed do not exceed 4 doses (120 mL or 8 TBSP) 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 30 mL dose cup contain...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 1050 mg

Purposes

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

OTC - DO NOT USE SECTION

  • 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 taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

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, 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • mL=milliliter
  • use dose cup or tablespoon (TBSP)
  • adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every hour as needed
  • do not exceed 4 doses (120 mL or 8 TBSP) 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 30 mL dose cup contains: magnesium 15 mg, sodium 7 mg
  • salicylate 436 mg
  • very low sodium
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)
  • store at 20-25°C (68-77°F)
  • TAMPER EVIDENT: Do not use if printed seal under cap is missing or broken.
  • does not meet USP requirements for pH

Inactive ingredients

INACTIVE INGREDIENT SECTION


Benzoic acid, D&C red No.22, D&C red No. 28, flavors, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, sucralose, xanthan gum


Questions or comments?

1-855-274-4122

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR BROKEN.

* This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto Bismol® Max Strength.


Distributed by:
CVS Pharmacy, Inc.
One CVS Drive,
Woonsocket, RI 02895
© 2016 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-33009


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL) Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health
Compare to the active ingredient in
Pepto-Bismol® Max Strength*
Cherry Flavor
NDC 69842-005-40
MAXIMUM STRENGTH
Stomach
Relief
BISMUTH SUBSALICYLATE
1050 mg PER 30 mL
Upset Stomach Reliever/Antidiarrheal
Soothing relief for 5 symptoms:

  • Heartburn
  • Indigestion
  • Upset stomach
  • Nausea
  • Diarrhea

Cherry Flavor

12 FL OZ (354 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL) BottlePACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL) Bottle

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-00569842-005-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
058d05d8-cf17-47d0-b6fe-57ec990067b05fc5459a-590c-41d4-bcde-720f664929852020-11-27WarningsExact identifier
spl set id: 5fc5459a-590c-41d4-bcde-720f66492985

Reported adverse events (FAERS/openFDA)#

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