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Pepto Bismol by JC World Bell Wholesale Co., Inc.

Medically reviewed on Jun 18, 2018

Dosage form: tablet
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: JC World Bell Wholesale Co., Inc.
NDC Code: 50269-476

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Pepto-Bismol Caplet

Drug Facts

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

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

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

Do not use

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

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

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.

Directions

• swallow with water, do not chew
• adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
• do not exceed 8 doses (16 caplets) 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 caplet contains: calcium 27 mg • salicylate 99 mg [• very low sodium] • avoid excessive heat (over 104ºF or 40ºC)

Inactive ingredients

calcium carbonate, D&C red No.27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

Questions?

1-800-717-3786

Package Labeling:

PEPTO BISMOL 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-476(NDC:37000-476)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
MAGNESIUM STEARATE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
POVIDONES 
SILICON DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize16mm
FlavorImprint CodePeptoBismol
Contains    
Packaging
#Item CodePackage Description
1NDC:50269-476-0120 POUCH in 1 BOX
12 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33506/16/2016
Labeler - JC World Bell Wholesale Co., Inc. (805257581)

 
JC World Bell Wholesale Co., Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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