FDA.reportPublic FDA data

STOMACH RELIEF

Manufacturer
Chain Drug Consortium, LLC | GCP Laboratories
Effective date
2020-03-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:37:59

Label at a glance#

ProductSTOMACH RELIEF
Active ingredientBISMUTH SUBSALICYLATE
Label structure8 sections

Indications and uses

relieves diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea

Dosage and administration

shake well before using drink plenty of clear fluids to help prevent dehydration caused by diarrhea for accurate dosing, use dose cup adults and children 12 years and over: take 2 tablespoonfuls every ½ to 1 hour as needed do not exceed 16 tablespoonfuls in 24 hours children under 12 years: ask a doctor

Storage and handling

each tablespoonful contains: sodium 6 mg, salicylate 130 mg low sodium sugar free protect from freezing avoid excessive heat (over 104°F or 40°C) visit www.info-xtra.com for health information TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL Tablespoonful)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea

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
  • 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

  • shake well before using
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: take 2 tablespoonfuls every ½ to 1 hour as needed
  • do not exceed 16 tablespoonfuls in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablespoonful contains: sodium 6 mg, salicylate 130 mg
  • low sodium
  • sugar free
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)
  • visit www.info-xtra.com for health information
  • TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, flavor, magnesium aluminum silicate, methylcellulose,
purified water, red 22, red 28, saccharin sodium, salicylic acid, simethicone emulsion,
sodium salicylate, sorbic acid, xanthan gum

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVPV

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
68016-39268016-392-08, 68016-392-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
METHYLCELLULOSE (100 CPS)4GFU244C4JIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SALICYLIC ACIDO414PZ4LPZIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM SALICYLATEWIQ1H85SYPIACT
SORBIC ACIDX045WJ989BIACT
XANTHAN GUMTTV12P4NEEIACT
METHYL SALICYLATELAV5U5022YIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

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
a22a98e4-95d0-2fd3-e053-2a95a90afecd60df0f08-6618-6cb5-e053-2a91aa0a77602020-03-31WarningsExact identifier
spl id: a22a98e4-95d0-2fd3-e053-2a95a90afecd
spl set id: 60df0f08-6618-6cb5-e053-2a91aa0a7760

Reported adverse events (FAERS/openFDA)#

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