Quality Choice Ultra Strength Stomach Relief 525mg

Quality Choice Ultra Strength Stomach Relief 525mg
SPL v2
SPL
SPL Set ID 67c610b1-fe94-4ad3-ad1a-8bd93a4da9d9
Route
ORAL
Published
Effective Date 2025-09-11
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 Gellan Gum (high Acyl) Microcrystalline Cellulose Potassium Hydroxide Potassium Sorbate Water Salicylic Acid Dimethicone, Unspecified Sodium Benzoate Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-07

Description

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal


Medication Information

Purpose

Upset stomach reliever/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
    • 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 and 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
  • 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 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
Do Not Use

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information
  • each 15 mL dose cup contains:potassium 7 mg, sodium 5 mg
  • salicylate 230 mg
  • low sodium
  • sugar free
  • protect from freezing
  • avoid excessive heat (more than 104ºF or 40ºC)
  • TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken
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.

Principal Display Panel

*Compare to the active ingredient in Pepto-Bismol® Ultra Strength

QUALITY CHOICE

Ultra Strength

Stomach Relief

Bismuth Subsalicylate 525 mg

Upset Stomach Reliever/ Antidiarrheal

Relieves:

Nausea, Heartburn, Indigestion, Upset Stomach & Diarrhea

2X CONCENTRATED FORMULA**

Original Flavor

8 FL OZ (236 mL)

100% QC SATISFACTION GURANTEED

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

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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.

Package Label for 12 Fl Oz 354 Ml
Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Active Ingredient (in Each 15 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
    • fullness
Purpose

Upset stomach reliever/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 and 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
  • 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 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
Do Not Use (Do not use)

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information (Other information)
  • each 15 mL dose cup contains:potassium 7 mg, sodium 5 mg
  • salicylate 230 mg
  • low sodium
  • sugar free
  • protect from freezing
  • avoid excessive heat (more than 104ºF or 40ºC)
  • TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken
Inactive Ingredients (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.

Principal Display Panel

*Compare to the active ingredient in Pepto-Bismol® Ultra Strength

QUALITY CHOICE

Ultra Strength

Stomach Relief

Bismuth Subsalicylate 525 mg

Upset Stomach Reliever/ Antidiarrheal

Relieves:

Nausea, Heartburn, Indigestion, Upset Stomach & Diarrhea

2X CONCENTRATED FORMULA**

Original Flavor

8 FL OZ (236 mL)

100% QC SATISFACTION GURANTEED

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

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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 at 1-800-222-1222.

Package Label for 12 Fl Oz 354 Ml (Package Label for 12 Fl OZ 354 ml)
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 15 Ml Dose) (Active ingredient (in each 15 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

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