pepto bismol ®

pepto bismol ®
SPL v10
SPL
SPL Set ID 851997d7-cb82-17bf-e053-2a91aa0ab78b
Route
oral
Published
Effective Date 2023-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (262 mg)
Inactive Ingredients
polysorbate 20 glycerin sorbitol titanium dioxide gelatin povidone d&c red no. 33 polyethylene glycol 400

Identifiers & Packaging

Pill Appearance
Imprint: PB Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
otc monograph drug completed Since 2018-03-01 Until 2026-06-30

Purpose

Antidiarrheal

Description

Drug Facts


Medication Information

Uses

relieves

  • travelers' diarrhea
  • diarrhea
Purpose

Antidiarrheal

Directions

• swallow with water, do not chew

• adults and children 12 years and over:

• 2 LiquiCaps every ½ hour or 4 LiquiCaps every 1 hour as needed

• do not exceed 16 LiquiCaps 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 LiquiCap contains:
  • salicylate 199 mg
  • low sodium
  • do not exceed 25°C
Inactive Ingredients

D&C red No. 33, gelatin, glycerin, polyethylene glycol, polysorbate 20, povidone, sorbitol sorbitan solution, titanium dioxide

Description

Drug Facts

Questions?

1-800-717-3786

Section 42229-5

Drug Facts

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.

Do Not Use if You Have
  • an ulcer
  • a bleeding problem
  • bloody or black stool
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 or last more than 2 days
  • 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.

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Active Ingredient (in Each Liquicap)

Bismuth subsalicylate 262 mg

Ask A Doctor Or Pharmacist Before Use

 if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Principal Display Panel 48 Liquicap Carton

FAST & SOOTHING RELIEF

Pepto®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

LIQUICAPS

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

48 LIQUICAPS™

Tamper Evident: This Package Is Safety Sealed & Child Resistant. Use Only If Blisters Are Intact. If Difficult to Open, Use Scissors.


Structured Label Content

Uses

relieves

  • travelers' diarrhea
  • diarrhea
Purpose

Antidiarrheal

Directions

• swallow with water, do not chew

• adults and children 12 years and over:

• 2 LiquiCaps every ½ hour or 4 LiquiCaps every 1 hour as needed

• do not exceed 16 LiquiCaps 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 LiquiCap contains:
  • salicylate 199 mg
  • low sodium
  • do not exceed 25°C
Inactive Ingredients (Inactive ingredients)

D&C red No. 33, gelatin, glycerin, polyethylene glycol, polysorbate 20, povidone, sorbitol sorbitan solution, titanium dioxide

Questions?

1-800-717-3786

Section 42229-5 (42229-5)

Drug Facts

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.

Do Not Use if You Have (Do not use if you have)
  • an ulcer
  • a bleeding problem
  • bloody or black stool
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 or last more than 2 days
  • 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Active Ingredient (in Each Liquicap) (Active ingredient (in each LiquiCap))

Bismuth subsalicylate 262 mg

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

 if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Principal Display Panel 48 Liquicap Carton (PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton)

FAST & SOOTHING RELIEF

Pepto®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

LIQUICAPS

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

48 LIQUICAPS™

Tamper Evident: This Package Is Safety Sealed & Child Resistant. Use Only If Blisters Are Intact. If Difficult to Open, Use Scissors. (TAMPER EVIDENT: THIS PACKAGE IS SAFETY SEALED & CHILD RESISTANT. USE ONLY IF BLISTERS ARE INTACT. IF DIFFICULT TO OPEN, USE SCISSORS.)


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Raw Label Data

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