FDA.reportPublic FDA data

SIGNATURE CARE

Manufacturer
SAFEWAY
Effective date
2026-02-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:46:48

Label at a glance#

ProductSIGNATURE CARE Ultra Strength Stomach
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 ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea ▪ 15 mL (1 dose) every ½ hour as needed 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 ...

Storage and handling

▪ each 15 mL dose cup contains: potassium 7 mg, sodium 5 mg ▪ salicylate 230 mg ▪ low sodium ▪ sugar free ▪ store at room temperature ▪ protect from freezing ▪ avoid excessive heat (over 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 ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
  • 15 mL (1 dose) every ½ hour as needed 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 dose cup contains: potassium 7 mg, sodium 5 mg
  • salicylate 230 mg
  • low sodium
  • sugar free
  • store at room temperature
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Do not use if imprinted shrink band is missing or broken.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Signature SELECT™

NDC 21130-193-12

COMPARE TO the active ingredient in Pepto-Bismol® *

STOMACH RELIEF

ULTRA STRENGTH

ORIGINAL FLAVOR

Bismuth Subsalicylate 525 MG

Upset Stomach Reliever/Antidiarrheal

Relief of:

  • Nausea, Heartburn, Indigestion, Upset Stomach, Diarrhea

12 FL. OZ. (354 mL)

2X CONCENTRATED FORMULA**

Distributed by: BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

‡1-888-723-3929

**vs Original Pepto Bismol®

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

Signature Select Ultra Strength Stomach Relief 354 mL
Signature Select Ultra Strength Stomach Relief 354 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN1
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD1
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY1
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130321130789642GTIN-13: 0321130789642
EAN-13: 0321130789642
GTIN-12: 321130789642
UPC-A: 321130789642
GTIN storage (14 digits): 00321130789642		302 88 stomach-relief-image.jpg
QR code linkQR Codealbtsn.com/ugtgk5j302 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
21130-193-12SIGNATURE CAREUltra Strength Stomach354 mL in 1 BOTTLESUSPENSION3541

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
21130-19321130-193-12

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
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
GELLAN GUM (LOW ACYL)7593U09I4DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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
SIGNATURE CARE Ultra Strength StomachBISMUTH SUBSALICYLATESAFEWAY4b54fa21-d8ea-4497-aa32-17e47669c8e12026-02-20WarningsExact identifier
ndc (package): 21130-193-12
ndc (product): 21130-193
ndc11 (package): 21130019312
spl id: 4b54fa21-d8ea-4497-aa32-17e47669c8e1
spl set id: 4b54fa21-d8ea-4497-aa32-17e47669c8e1

Reported adverse events (FAERS/openFDA)#

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