pepto-bismol™

pepto-bismol™
SPL v17
SPL
SPL Set ID e02bead2-0be9-41b0-98a7-fd0c3f57def0
Route
oral
Published
Effective Date 2023-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (262 mg)
Inactive Ingredients
calcium carbonate magnesium stearate mannitol povidone, unspecified d&c red no. 27 aluminum lake saccharin sodium talc

Identifiers & Packaging

Pill Appearance
Imprint: Pepto;Bismol Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
otc monograph final active Since 2004-06-30

Purpose

Upset stomach reliever and antidiarrheal

How Supplied

Product: 50090-0553 NDC: 50090-0553-0 6 TABLET in a CELLO PACK / 5 in a CARTON

Description

Drug Facts


Medication Information

Active Ingredient

Bismuth subsalicylate 262 mg

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Purpose

Upset stomach reliever and antidiarrheal

Directions
  • chew or dissolve in mouth
  • adults and children 12 years and over:
  • 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information
  • each tablet contains: calcium 140 mg, magnesium 9 mg
  • salicylate 101 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

How Supplied

Product: 50090-0553

NDC: 50090-0553-0 6 TABLET in a CELLO PACK / 5 in a CARTON

Description

Drug Facts

Questions?

1-800-717-3786

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

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Section 53414-9

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

Purposes

Upset stomach reliever and antidiarrheal

Allergy Alert

Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
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.

Bismuth Subsalicylate

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Bismuth subsalicylate 262 mg

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Directions
  • chew or dissolve in mouth
  • adults and children 12 years and over:
  • 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information (Other information)
  • each tablet contains: calcium 140 mg, magnesium 9 mg
  • salicylate 101 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

How Supplied (HOW SUPPLIED)

Product: 50090-0553

NDC: 50090-0553-0 6 TABLET in a CELLO PACK / 5 in a CARTON

Questions?

1-800-717-3786

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

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Section 53414-9 (53414-9)

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

Purposes

Upset stomach reliever and antidiarrheal

Allergy Alert (Allergy alert)

Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Reye's Syndrome (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.

Bismuth Subsalicylate (Bismuth subsalicylate)

Advanced Ingredient Data


Raw Label Data

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