NDC 63187-650 Bismatrol
Bismuth Subsalicylate Tablet, Chewable Oral

Product Information

What is NDC 63187-650?

The NDC code 63187-650 is assigned by the FDA to the product Bismatrol which is a human over the counter drug product labeled by Proficient Rx Lp. The generic name of Bismatrol is bismuth subsalicylate. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 63187-650-30 5 blister pack in 1 carton / 6 tablet, chewable in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code63187-650
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.
Bismatrol
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.
Proficient Rx Lp
Labeler Code63187
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.
01-03-2003
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.
12-31-2023
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

What are the uses for Bismatrol?


Product Characteristics

Color(s)PINK (C48328)
ShapeROUND (C48348)
Size(s)17 MM
Imprint(s)GDC122
Score1

Product Packages

NDC Code 63187-650-30

Package Description: 5 BLISTER PACK in 1 CARTON / 6 TABLET, CHEWABLE in 1 BLISTER PACK

Product Details

What are Bismatrol Active Ingredients?

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.

Bismatrol Active Ingredients UNII Codes

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 code indicates a single concept unique identifier (RXCUI) is associated with this product:

Bismatrol Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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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]

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Bismatrol Product Label

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.

Product Label Table of Contents



Active Ingredient (In Each Tablet)



Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)


Purpose



Upset stomach reliever and anti-diarrheal


Uses



relieves:

  • •diarrhea
  • •heartburn
  • •indigestion
  • •nausea
  • •upset stomach associated with these symptoms

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



  • •bloody or black stools
  • •an ulcer
  • •a bleeding problem

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 of 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

Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.


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 take more than 8 doses (16 tablets) in 24 hours
  • •children under 12 years: ask a doctor
  • •drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
  • Other information: each tablet contains:

    • •sodium less than 1 mg
    • •salicylate 102 mg
    • •calcium 140 mg
    • •very low sodium
    • •avoid excessive heat (over 104˚F or 40˚C)
    • TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

Inactive Ingredients



calcium carbonate, D and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.


Principal Display Panel



MAJOR

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Bismatrol Chewable Tablets

soothing, coating action provides fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea

compare to the active ingredient in Pepto-Bismol®

30 chewable tablets


* Please review the disclaimer below.