NDC 67751-155 Pepto Bismol
Bismuth Subsalicylate Tablet, Chewable Oral

Product Information

Product Code67751-155
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Pepto Bismol
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Bismuth Subsalicylate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormTablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Navajo Manufacturing Company Inc.
Labeler Code67751
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part335
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-20-2016
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)PINK (C48328)
ShapeROUND (C48348)
Size(s)16 MM
Imprint(s)PEPTO;BISMOL
Score1
Flavor(s)WINTERGREEN (C73424)

Product Packages

NDC 67751-155-01

Package Description: 1 POUCH in 1 CARTON > 2 TABLET, CHEWABLE in 1 POUCH

NDC 67751-155-02

Package Description: 1 POUCH in 1 CARTON > 4 TABLET, CHEWABLE in 1 POUCH

Product Details

Pepto Bismol is a human over the counter drug product labeled by Navajo Manufacturing Company Inc.. The generic name of Pepto Bismol is bismuth subsalicylate. The product's dosage form is tablet, chewable and is administered via oral form.


What are Pepto Bismol Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)


* Please review the disclaimer below.

Patient Education

Bismuth Subsalicylate

Bismuth Subsalicylate is pronounced as (biz muth) (sub sa lis' i late)

Why is bismuth subsalicylate medication prescribed?
Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of med...
[Read More]

* Please review the disclaimer below.

Pepto Bismol Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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:




* Please review the disclaimer below.