pepto bismol ®

pepto bismol ®
SPL v11
SPL
SPL Set ID 84ffa6d6-03e1-59e8-e053-2a91aa0afd6e
Route
oral
Published
Effective Date 2023-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Purpose

Upset stomach reliever and antidiarrheal

Description

Drug Facts


Medication Information

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

• swallow with water, do not chew

• adults and children 12 years and over:

• 2 LiquiCaps every ½ hour or 4 LiquiCaps every hour as needed for diarrhea

• 2 LiquiCaps every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• 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 34088-5

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Do Not Use If

you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
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.

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.

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

Bismuth subsalicylate 262 mg

Principal Display Panel 48 Liquicap Carton

FAST & SOOTHING RELIEF

Pepto

Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

LIQUICAPS

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

48 LIQUICAPS™

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:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
Purpose

Upset stomach reliever and antidiarrheal

Directions

• swallow with water, do not chew

• adults and children 12 years and over:

• 2 LiquiCaps every ½ hour or 4 LiquiCaps every hour as needed for diarrhea

• 2 LiquiCaps every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• 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 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Do Not Use If (Do not use if)

you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
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.

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.

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

Principal Display Panel 48 Liquicap Carton (PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton)

FAST & SOOTHING RELIEF

Pepto

Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

LIQUICAPS

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

48 LIQUICAPS™

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

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