Stomach Relief

Manufacturer
Hannaford Brothers Company
Effective date
2010-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:50:54

Label at a glance#

ProductStomach Relief Original Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 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 for accurate dosing, use dose cup adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (16 Tbsp or 240 mL) 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

Storage and handling

each Tbsp contains: magnesium 5 mg, potassium 5 mg and sodium 5 mg salicylate 123 mg protect from freezing sugar free low sodium does not meet USP requirements for pH for health information visit www.more-info.info

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL Tablespoon)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 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:
  • 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

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)
  • 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

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 Tbsp or 240 mL) 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

STORAGE AND HANDLING SECTION

  • each Tbsp contains: magnesium 5 mg, potassium 5 mg and sodium 5 mg
  • salicylate 123 mg
  • protect from freezing
  • sugar free
  • low sodium
  • does not meet USP requirements for pH
  • for health information visit www.more-info.info www.more-info.info

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-213-9040

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Original Pepto-Bismol® active ingredient

Bismuth Subsalicylate 262 mg

Stomach Relief

Original Strength

Upset Stomach Reliever

Antidiarrheal

Protective Coating Action

Soothing Relief For 5 Symptoms:

Heartburn

Indigestion

Upset Stomach

Nausea

Diarrhea

Stomach Relief Label
Stomach Relief Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR11
BISMUTH SUBSALICYLATEACTIVE MOIETY62TEY51RR11
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RT1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NH1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ1
SODIUM SALICYLATEINACTIVE INGREDIENTWIQ1H85SYP1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41268-30241268-302-34, 41268-302-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 115 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHPOWDER, FOR SUSPENSION / ORAL0.7 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BEMULSION / OPHTHALMIC1 mgExact identifier — unii candidate
19 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / SUBLINGUAL0.16 mgExact identifier — unii candidate
19 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTCAPSULE / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCGRANULE, FOR SUSPENSION / ORAL12.5 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSYRUP / ORAL100 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTTABLET, DELAYED RELEASE / ORAL0.38 mgExact identifier — unii candidate
5 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
19 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / RECTAL0.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
17 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
17 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHAEROSOL / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHSUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / RECTAL14480 mgExact identifier — unii candidate
17 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates

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
58073a75-b4b2-4a09-9535-0b2c5a687f6de7c71ec8-1d75-458d-924b-97c3347b09932020-04-14WarningsExact identifier
spl set id: e7c71ec8-1d75-458d-924b-97c3347b0993

Reported adverse events (FAERS/openFDA)#

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