Equate 44-749

SPL v7

SPL

SPL Set ID ef63ce58-f70e-429d-a154-c0a561511c04

Route

ORAL

Published

Effective Date 2025-03-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (525 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;749 Shape: oval Color: pink Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-04-06

Description

Bismuth subsalicylate 525 mg

Purpose

Antidiarrheal

Medication Information

Purpose

Antidiarrheal

Description

Bismuth subsalicylate 525 mg

Uses

relieves

travelers' diarrhea
diarrhea

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

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
swallow with water; do not chew
adults and children 12 years and over: 1 caplet every 1/2 hour or 2 caplets every hour as needed
do not exceed 8 caplets in 24 hours
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 45 mg, salicylate 206 mg, sodium 3 mg
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
avoid excessive heat
use by expiration date on package

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?

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-769-08

Compare to the active ingredient in Pepto® Diarrhea*

MAXIMUM STRENGTH

Anti-Diarrheal

Bismuth Subsalicylate 525 mg

Anti-Diarrheal

Relieves Diarrhea

Actual Size

525 mg EACH

24 CAPLETS

TAMPER EVIDENT: DO NOT

USE IF IMPRINTED SAFETY SEAL

UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by

The Procter & Gamble Company, owner of the registered

trademark Pepto® Diarrhea.

50844 ORG121974908

Equate 44-749

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 525 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

anticoagulation (thinning the blood)
gout
diabetes
arthritis

Structured Label Content

Uses

relieves

travelers' diarrhea
diarrhea

Purpose

Antidiarrheal

Warnings

Allergy alert: Contains salicylate. Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Directions

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
swallow with water; do not chew
adults and children 12 years and over: 1 caplet every 1/2 hour or 2 caplets every hour as needed
do not exceed 8 caplets in 24 hours
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 45 mg, salicylate 206 mg, sodium 3 mg
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
avoid excessive heat
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel (Principal display panel)

equate™

NDC 49035-769-08

Compare to the active ingredient in Pepto® Diarrhea*

MAXIMUM STRENGTH

Anti-Diarrheal

Bismuth Subsalicylate 525 mg

Anti-Diarrheal

Relieves Diarrhea

Actual Size

525 mg EACH

24 CAPLETS

TAMPER EVIDENT: DO NOT

USE IF IMPRINTED SAFETY SEAL

UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by

The Procter & Gamble Company, owner of the registered

trademark Pepto® Diarrhea.

50844 ORG121974908

Equate 44-749

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 525 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

anticoagulation (thinning the blood)
gout
diabetes
arthritis

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves travelers' diarrhea diarrhea", "Purpose": "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": "drink plenty of clear fluids to help prevent dehydration caused by diarrhea swallow with water; do not chew adults and children 12 years and over: 1 caplet every 1/2 hour or 2 caplets every hour as needed do not exceed 8 caplets in 24 hours 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 45 mg, salicylate 206 mg, sodium 3 mg store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive heat use by expiration date on package", "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?": "1-888-287-1915", "Principal display panel": "equate ™ NDC 49035-769-08 Compare to the active ingredient in Pepto® Diarrhea* MAXIMUM STRENGTH Anti-Diarrheal Bismuth Subsalicylate 525 mg Anti-Diarrheal Relieves Diarrhea Actual Size 525 mg EACH 24 CAPLETS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 * This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Pepto® Diarrhea. 50844 ORG121974908 Equate 44-749", "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 525 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 anticoagulation (thinning the blood) gout diabetes arthritis "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:41.687119 · Updated: 2026-03-14T23:07:53.934759