PEPTO BISMOL- bismuth subsalicylate tablet, chewable 
Navajo Manufacturing Company Inc.

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Pepto Bismol

Drug Facts

Active ingredient (in each Chewable tablet)

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 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.

Directions

• chew or dissolve in mouth
• adults and children 12 years and over:

• 2 tablets every 1/2 to 1 hour as needed
• 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
• very low sodium
• protect from freezing
• avoid excessive heat (over 104°F or 40°C)

• do not use if pouch is opened

Inactive ingredients

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

Questions?

1-800-717-3786

Package Labeling:

Pepto

PEPTO BISMOL 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-155(NDC:58933-011)
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)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorWINTERGREENImprint Code Pepto;Bismol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-155-011 in 1 CARTON09/20/2016
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:67751-155-021 in 1 CARTON09/20/2016
24 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00809/20/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411repack(67751-155) , relabel(67751-155)

Revised: 4/2024
Document Id: f70ba21d-547b-8887-e053-6394a90a696a
Set id: 033bccc6-6e81-487f-91fe-9d7cc465e1b2
Version: 3
Effective Time: 20240415
 
Navajo Manufacturing Company Inc.