Quality Choice 44-346

Quality Choice 44-346
SPL v3
SPL
SPL Set ID d63110ee-2d64-46dd-80bf-696c9b9d8d7c
Route
ORAL
Published
Effective Date 2026-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Calcium Carbonate Starch, Corn D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Magnesium Stearate Mannitol Microcrystalline Cellulose Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;346 Shape: oval Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-14

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/antidiarrheal 


Medication Information

Purpose

Upset stomach reliever/antidiarrheal 

Description

Bismuth subsalicylate 262 mg

Uses

relieves:

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • belching
    • indigestion
    • gas
    • fullness
    • heartburn
    • nausea
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
  • do not take more than directed
  • swallow with water; do not chew
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.

  • do not use for more than 2 days unless directed by a doctor
  • use until diarrhea stops, but not more than 2 days
  • children under 12 years: ask a doctor
Do Not Use

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool 
Other Information
  • each caplet contains: calcium 20 mg, salicylate 103 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number 
Inactive Ingredients

calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 83324-060-40

*Compare to the

Active Ingredient in

Pepto-Bismol®

Stomach Relief

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever/Antidiarrheal

Relieves Nausea, Heartburn, Indigestion,

Upset Stomach, Diarrhea

40 Caplets

Actual Size

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

The Procter & Gamble Company, owner of the

registered trademark Pepto-Bismol®.

50844            REV0521B34610

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION

100%

GUARANTEED®

Quality Choice 44-346
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
  • 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.

Active Ingredient (in Each Caplet)

Bismuth subsalicylate 262 mg

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

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

Structured Label Content

Uses

relieves:

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • belching
    • indigestion
    • gas
    • fullness
    • heartburn
    • nausea
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
  • do not take more than directed
  • swallow with water; do not chew
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.

  • do not use for more than 2 days unless directed by a doctor
  • use until diarrhea stops, but not more than 2 days
  • children under 12 years: ask a doctor
Do Not Use (Do not use)

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool 
Other Information (Other information)
  • each caplet contains: calcium 20 mg, salicylate 103 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number 
Inactive Ingredients (Inactive ingredients)

calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

QC®

QUALITY

CHOICE

NDC 83324-060-40

*Compare to the

Active Ingredient in

Pepto-Bismol®

Stomach Relief

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever/Antidiarrheal

Relieves Nausea, Heartburn, Indigestion,

Upset Stomach, Diarrhea

40 Caplets

Actual Size

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

The Procter & Gamble Company, owner of the

registered trademark Pepto-Bismol®.

50844            REV0521B34610

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION

100%

GUARANTEED®

Quality Choice 44-346
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
  • 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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool 
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any drug for

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

Advanced Ingredient Data


Raw Label Data

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