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Pepto Bismol by Navajo Manufacturing Company Inc.

Medically reviewed on October 27, 2016

Dosage form: tablet, chewable
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-155

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

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 BISMOL 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-155(NDC:37000-477)
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 
D&C RED NO. 27 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
MANNITOL 
POVIDONE 
SACCHARIN SODIUM 
TALC 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorWINTERGREENImprint CodePepto;Bismol
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-155-011 POUCH in 1 CARTON
12 TABLET, CHEWABLE in 1 POUCH
2NDC:67751-155-021 POUCH in 1 CARTON
24 TABLET, CHEWABLE in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33509/20/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)

 
Navajo Manufacturing Company Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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