Equate 44-346

Equate 44-346
SPL v17
SPL
SPL Set ID 2d7d563e-4c46-4788-b6a7-5b92e3d58533
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 2019-07-30

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 ½ 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?

1-888-287-1915

Principal Display Panel

equate

NDC 49035-346-10

Compare to

Pepto-Bismol®

active

ingredient*

Stomach

Relief

Bismuth Subsalicylate

262 mg

Upset Stomach Reliever/

Antidiarrheal

Relieves

• Nausea

• Heartburn

• Indigestion

• Upset stomach

• Diarrhea

262

mg

EACH 

40

CAPLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Satisfaction guaranteed - Or we'll replace it or

give you your money back. For questions or

comments please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

PRODUCT OF GERMANY AND MEXICO

*This product is not manufactured or distributed by The

Procter & Gamble Company, owner of the registered

trademark Pepto-Bismol®.     50844     REV0521B34610

Equate 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

  • 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:
    • 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 ½ 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?)

1-888-287-1915

Principal Display Panel (Principal display panel)

equate

NDC 49035-346-10

Compare to

Pepto-Bismol®

active

ingredient*

Stomach

Relief

Bismuth Subsalicylate

262 mg

Upset Stomach Reliever/

Antidiarrheal

Relieves

• Nausea

• Heartburn

• Indigestion

• Upset stomach

• Diarrhea

262

mg

EACH 

40

CAPLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Satisfaction guaranteed - Or we'll replace it or

give you your money back. For questions or

comments please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

PRODUCT OF GERMANY AND MEXICO

*This product is not manufactured or distributed by The

Procter & Gamble Company, owner of the registered

trademark Pepto-Bismol®.     50844     REV0521B34610

Equate 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

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)