PEPTO BISMOL- bismuth subsalicylate tablet 
JC World Bell Wholesale Co., Inc.

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.

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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:

Label

PEPTO BISMOL 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-476(NDC:37000-476)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize16mm
FlavorImprint Code PeptoBismol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50269-476-0120 in 1 BOX06/16/201608/01/2022
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33506/16/201608/01/2022
Labeler - JC World Bell Wholesale Co., Inc. (805257581)

Revised: 10/2021
Document Id: ceb8a879-9ff2-1d99-e053-2a95a90a9bb0
Set id: aa7039b0-5e5c-439c-99aa-a7ac217ffeaf
Version: 4
Effective Time: 20211019
 
JC World Bell Wholesale Co., Inc.