Quality Choice 44-346 Delisted

SPL v6

SPL

SPL Set ID e1552f01-ab98-41c7-a7be-aedf2d40e437

Route

ORAL

Published

Effective Date 2025-10-10

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 Completed Since 2021-03-31 Until 2026-08-31

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 63868-691-40

*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

actual size

40 Caplets

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 REV0521A34610

SATISFACTION

GUARANTEED

100% QC

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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

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)

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

QC®

QUALITY

CHOICE

NDC 63868-691-40

*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

actual size

40 Caplets

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 REV0521A34610

SATISFACTION

GUARANTEED

100% QC

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

[{"name": "BISMUTH CATION", "unii": "ZS9CD1I8YE", "classCode": "ACTIB", "strengthNumerator": "262", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 30 ALUMINUM LAKE", "unii": "GE75M6YV5W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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 63868-691-40 *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 actual size 40 Caplets 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 REV0521A34610 SATISFACTION GUARANTEED 100% QC Distributed by C.D.M.A., Inc.© 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:56.817356 · Updated: 2026-03-14T23:13:00.870746