FDA.reportPublic FDA data

TopCare Stomach Relief

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:43:13

Label at a glance#

ProductTopCare Stomach Relief Ultra 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 Only use dose cup provided adults and children 12 years and over: 15 mL (1 dose) every 1/2 or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea. 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a...

Storage and handling

each 15 mL contains: sodium 10 mg salicylate 230 mg low sodium sugar free store at room temperature protect from freezing avoid excessive heat (over than 104°F or 40°C)

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 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 or 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

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 or last more than 2 days
  • 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 at (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • Only use dose cup provided
  • adults and children 12 years and over:15 mL (1 dose) every 1/2 or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea.
  • 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (120 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 15 mL contains:sodium 10 mg
  • salicylate 230 mg
  • low sodium
  • sugar free
  • store at room temperature
  • protect from freezing
  • avoid excessive heat (over than 104°F or 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare ®health ™

COMPARE TO PEPTO-BISMOL ®ULTRA STRENGTH ACTIVE INGREDIENT*

ULTRA STRENGTH

Stomach Relief

BISMUTH SUBSALICYLATE 525 mg per 15 mL

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 SYSMPTOM DIGESTIVE RELIEF

  • Heartburn
  • Indigestion
  • Upset Stomach
  • Nausea
  • Diarrhea

OUR PHARMACISTS RECOMMEND

QUALITY GURANTEED

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO RARA0919

QUESTIONS? 1-888-423-0139

topcare@topco.com, www.topcarebrand.com

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

Package Label 354 mL

TopCare Ultra Strength Stomach 354 mL doses
TopCare Ultra Strength Stomach 354 mL doses

Package Label 236 mL

SPL UNCLASSIFIED SECTION

TopCare Ultra Strength Stomach 236 mL doses
TopCare Ultra Strength Stomach 236 mL doses

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN7
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD7
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY7
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800135857GTIN-13: 0036800135857
EAN-13: 0036800135857
GTIN-12: 036800135857
UPC-A: 036800135857
GTIN storage (14 digits): 00036800135857		302 88 stomach-relief-image.jpg
BarcodeEAN-130036800993297GTIN-13: 0036800993297
EAN-13: 0036800993297
GTIN-12: 036800993297
UPC-A: 036800993297
GTIN storage (14 digits): 00036800993297		70708TOP 236ml artwork.png.jpg.jpg
QR code linkQR Codetopbrnds.com/48zzsa302 88 stomach-relief-image.jpg

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
36800-341-08TopCare Stomach ReliefUltra Strength236 mL in 1 BOTTLESUSPENSION2367
36800-341-12TopCare Stomach ReliefUltra Strength354 mL in 1 BOTTLESUSPENSION3547

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-34136800-341-12, 36800-341-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-06full-release2026-06-01 00:34:34

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
TopCare Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLCe745e693-9e45-43b0-b26c-99ca891b74b02025-11-10WarningsExact identifier
ndc (package): 36800-341-12
ndc (package): 36800-341-08
ndc (product): 36800-341
ndc11 (package): 36800034108
ndc11 (package): 36800034112
spl id: 433b9bca-9b39-cacb-e063-6294a90a7523
spl set id: e745e693-9e45-43b0-b26c-99ca891b74b0

Reported adverse events (FAERS/openFDA)#

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