bismuth subsalicylate 262 mg

bismuth subsalicylate 262 mg
SPL v6
SPL
SPL Set ID 2e40ffd8-1afa-43af-e054-00144ff8d46c
Route
oral
Published
Effective Date 2015-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (262 mg)
Inactive Ingredients
calcium carbonate dextrose cherry magnesium stearate maltodextrin d&c red no. 27 silicon dioxide sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: AP;045 Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2015-11-01
Purpose

Anti-diarrheal / Upset stomach reliever

Description

Drug Facts

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.

Active Ingredient

Bismuth subsalicylate 262 mg

Uses
  • controls diarrhea
  • relieves upset stomach due to overindulgence in food or drink
Purpose

Anti-diarrheal / Upset stomach reliever

Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults and children 12 years and over: 2 tablets
  • children under 12 years: ask a doctor
Other Information
  • each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredients

calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
Section 50567-7

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3

Ask a doctor before use if you have

  • fever
  • mucus in the stool
Section 50570-1

Do not use

  • if you have bloody or black stool
  • if you have an ulcer or bleeding problem

Drug Facts continued on back of label

Section 51945-4

NDC 69618-029-03

Bismuth Subsalicylate

262 mg

UPSET STOMACH RELIEVER / ANTIDIARRHEAL

30 CHEWABLE TABLETS

*compare to Active Ingredients in Pepto-Bismol®

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Purposes

Anti-diarrheal / Upset stomach reliever

Questions Or Comments?

call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

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.

Active Ingredient (Active ingredient (in each tablet))

Bismuth subsalicylate 262 mg

Uses
  • controls diarrhea
  • relieves upset stomach due to overindulgence in food or drink
Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults and children 12 years and over: 2 tablets
  • children under 12 years: ask a doctor
Other Information (Other information)
  • each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • fever
  • mucus in the stool
Section 50570-1 (50570-1)

Do not use

  • if you have bloody or black stool
  • if you have an ulcer or bleeding problem

Drug Facts continued on back of label

Section 51945-4 (51945-4)

NDC 69618-029-03

Bismuth Subsalicylate

262 mg

UPSET STOMACH RELIEVER / ANTIDIARRHEAL

30 CHEWABLE TABLETS

*compare to Active Ingredients in Pepto-Bismol®

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purposes

Anti-diarrheal / Upset stomach reliever

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:22.051678 · Updated: 2026-03-14T23:07:03.829205