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

Purpose

Upset stomach reliever/Antidiarrheal

Description

Bismuth subsalicylate 525 mg


Medication Information

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
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

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
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.

Description

Bismuth subsalicylate 525 mg

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

Do Not Use

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
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

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
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

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
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

Do Not Use (Do not use)

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
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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