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 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

•: 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 104°F or 40°C)

Inactive ingredients

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?

Call 800-824-1706 Monday – Friday 9am – 4pm MST

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

Principal Display Panel

WinCo® FOODS

Compare to active ingredient PEPTO-BISMOL® Ultra Strength

ULTRA STRENGTH

Stomach Relief

BISMUTH SUBSALICYLATE

UPSET STOMACH RELIEVER & ANTI-DIARRHEAL

Soothing Relief for: Upset Stomach, Nausea, Heartburn & Diarrhea

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by PROCTER & GAMBLE INC., distributor of PEPTO-BISMOL® Ultra Strength

WINCO FOODS ULTRA STRENGTH STOMACH RELIEF
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67091-363
Route of Administration	ORAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67091-363-24	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M008	02/25/2020

Labeler - WINCO FOODS (056098817)

WinCo FOODS Ultra Strength Stomach Relief Drug Facts