Winco ®

Winco ®
SPL v6
SPL
SPL Set ID 19c14efc-bf5f-4ef5-a727-aaccfae093f0
Route
ORAL
Published
Effective Date 2020-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified D&c Red No. 22 D&c Red No. 28 Microcrystalline Cellulose Potassium Hydroxide Potassium Sorbate Water Salicylic Acid Dimethicone, Unspecified Sodium Benzoate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-24

Description

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 525 mg

Uses

relieves

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

Upset stomach reliever and antidiarrheal

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
Directions
  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over:(30 mL) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
  • 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (240 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
Questions?

Call 1-800-824-1706 Monday – Friday 9am – 4pm MST

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

Other Information
  • each 30 mL contains:sodium 10 mg
  • salicylate 261 mg
  • low sodium
  • sugar free
  • store at room temperature
  • protect from freezing
  • avoid excessive heat (more than 104°F 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

Do Not Use If You Have
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Principal Display Panel

WinCo ®FOODS

NDC# 67091-362-23

Compare To the active ingredient in PEPTO-BISMOL® Regular Strength.

Stomach Relief

BISMUTH SUBSALICYLATE/

UPSET STOMACH RELIEVER & ANTI-DIARRHEAL

Soothing Relief from:Upset Stomach ,Indigestion ,Nausea ,Heartburn &Diarrhea

Regular Strength

8 FL. OZ. (236 mL)

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

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

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 (1-800-222-1222).

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Active Ingredient (in Each 30 Ml Dose)

Bismuth subsalicylate 525 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

Uses

relieves

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

Upset stomach reliever and antidiarrheal

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
Directions
  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over:(30 mL) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
  • 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (240 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
Questions?

Call 1-800-824-1706 Monday – Friday 9am – 4pm MST

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

Other Information (Other information)
  • each 30 mL contains:sodium 10 mg
  • salicylate 261 mg
  • low sodium
  • sugar free
  • store at room temperature
  • protect from freezing
  • avoid excessive heat (more than 104°F 40°C)
Inactive Ingredients (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

Do Not Use If You Have (Do not use if you have)
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Principal Display Panel

WinCo ®FOODS

NDC# 67091-362-23

Compare To the active ingredient in PEPTO-BISMOL® Regular Strength.

Stomach Relief

BISMUTH SUBSALICYLATE/

UPSET STOMACH RELIEVER & ANTI-DIARRHEAL

Soothing Relief from:Upset Stomach ,Indigestion ,Nausea ,Heartburn &Diarrhea

Regular Strength

8 FL. OZ. (236 mL)

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

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

When Using This Product (When using this product)

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Active Ingredient (in Each 30 Ml Dose) (Active ingredient (in each 30 mL dose))

Bismuth subsalicylate 525 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)