SIGNATURE CARE ULTRA STRENGTH STOMACH- bismuth subsalicylate suspension

SIGNATURE CARE by

Drug Labeling and Warnings

SIGNATURE CARE by is a Otc medication manufactured, distributed, or labeled by SAFEWAY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL dose)

Bismuth subsalicylate 525 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

• ▪ travelers’ diarrhea
• ▪ diarrhea
• ▪ upset stomach due to overindulgence in food and drink, including:
• ▪ heartburn
• ▪ indigestion
• ▪ nausea
• ▪ gas
• ▪ belching
• ▪ fullness

Warnings

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

• ▪ 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 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,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

• ▪ 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

• ▪ 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

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?

1-866-467-2748

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

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.

INGREDIENTS AND APPEARANCE

SIGNATURE CARE  ULTRA STRENGTH STOMACH
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-193
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK (viscous)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-193-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	02/02/2026

Labeler - SAFEWAY (009137209)