Stomach Relief

Manufacturer
CDMA- QC
Effective date
2021-06-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:04

Label at a glance#

ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Dosage and administration

Chew or dissolve in mouth Adults and children 12 years and over : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea  2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) in 24 hours use until diarrhea stops but not more than 2 days Children under 12 years of age: ask a doctor drink plen...

Storage and handling

Store at room temperature 15°– 30°C (59°– 86°F)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

Purpose

OTC - PURPOSE SECTION

Antidiarrheal/Antacid

Use(s)

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

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking any drug for

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

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 accidental overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Chew or dissolve in mouth

Adults and children 12 years and over:

  • 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every
    hour as needed for diarrhea 
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset
    stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days

Children under 12 years of age: ask a doctor

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

SPL UNCLASSIFIED SECTION

Phenylketonurics: contains phenylalanine 1.1mg per tablet Calcium content per tablet: 73mg

Do not use if cellophane unit is torn

Storage

STORAGE AND HANDLING SECTION

Store at room temperature 15°– 30°C (59°– 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum
lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stomach ReliefStomach Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN3
308761bismuth subsalicylate 262 MG Chewable TabletSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-622-30Stomach Relief30 in 1 CELLO PACKTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-622STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET [CDMA- QC]3Current NDC, Legacy NDC, 1 package rows20231020_fe3cd0ce-933b-4ad3-a34f-c057a9356158.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-622-30EA - Each63868-6223442fe87-878b-40b6-9c2f-d455adfd4d4512022-08-04

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-62263868-622-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
Stomach ReliefBISMUTH SUBSALICYLATECDMA- QCfe3cd0ce-933b-4ad3-a34f-c057a93561582021-06-16WarningsExact identifier
ndc (package): 63868-622-30
ndc (product): 63868-622
ndc11 (package): 63868062230
spl id: 25788bd2-f666-4c2f-9977-b343388c0c08
spl set id: fe3cd0ce-933b-4ad3-a34f-c057a9356158

Reported adverse events (FAERS/openFDA)#

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