NDC 63868-339 Qc Anti Diarrheal Vanilla Regular Flavor
Bismuth Subsalicylate Suspension Oral

Product Information

What is NDC 63868-339?

The NDC code 63868-339 is assigned by the FDA to the product Qc Anti Diarrheal Vanilla Regular Flavor which is a human over the counter drug product labeled by Quality Choice (chain Drug Marketing Association). The generic name of Qc Anti Diarrheal Vanilla Regular Flavor is bismuth subsalicylate. The product's dosage form is suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 63868-339-12 355 ml in 1 bottle, plastic . 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 Code63868-339
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.
Qc Anti Diarrheal Vanilla Regular Flavor
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 FormSuspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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.
Quality Choice (chain Drug Marketing Association)
Labeler Code63868
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.
04-16-2019
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 Qc Anti Diarrheal Vanilla Regular Flavor?


Product Characteristics

Color(s)WHITE (C48325)
Flavor(s)VANILLA (C73421 - REGULAR)

Product Packages

NDC Code 63868-339-12

Package Description: 355 mL in 1 BOTTLE, PLASTIC

Product Details

What are Qc Anti Diarrheal Vanilla Regular Flavor 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.

Qc Anti Diarrheal Vanilla Regular Flavor 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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 308762 - bismuth subsalicylate 525 MG in 30 mL Oral Suspension
  • RxCUI: 308762 - bismuth subsalicylate 17.5 MG/ML Oral Suspension
  • RxCUI: 308762 - bismuth subsalicylate 1.75 % Oral Suspension
  • RxCUI: 308762 - bismuth subsalicylate 262 MG per 15 ML Oral Suspension
  • RxCUI: 308762 - bismuth subsalicylate 524 MG per 30 ML Oral Suspension

Qc Anti Diarrheal Vanilla Regular Flavor 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.

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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]

* Please review the disclaimer below.

Qc Anti Diarrheal Vanilla Regular Flavor 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



Other



Drug Facts


Active Ingredient (Per 15 Ml)



Bismuth subsalicylate 262 mg


Purposes



Antidiarrheal/Upset stomach reliever


Uses



Relieves

  • ▪traveler’s diarrhea
  • ▪diarrhea
  • ▪upset stomach due to overindulgence in food and drink
  • ▪heartburn
  • ▪indigestion
  • ▪nausea
  • ▪gas

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

Otc - Do Not Use



Do not use if you have

  • ▪an ulcer
  • ▪a bleeding problem
  • ▪bloody or black stool

Otc - Ask Doctor



Ask a doctor before use if you have

  • ▪fever
  • ▪mucus in the stool

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking any drug for

  • ▪diabetes
  • ▪gout
  • ▪arthritis
  • ▪anticoagulation (thinning the blood)

Otc - When Using



When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur


Otc - Stop Use



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - 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 right away at 1-800-222-1222.


Directions



  • shake well immediately before each use
  • ▪adults and children 12 years of age and older : 30 ml or 2 tablespoonful
  • ▪for accurate dosing, use convenient pre-measured dose cup
  • ▪repeat dose every 1/2 hour to 1 hour as needed
  • ▪do not exceed 8 doses 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 15mL tablespoon contains: sodium 10 mg
  • each 15mL tablespoon contains: salicylate 130 mg
  • do not use if printed inner seal is broken or missing
  • ▪store at room temperature

Inactive Ingredients



caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum


Questions Or Comments?



1-866-467-2748


Principal Display Panel - 355 Ml Bottle Label



NDC 63868-339-12

Compare to the active ingredient in Kaopectate®

Diarrhea Relief

Bismuth Subsalicylate, 262 mg

Bismuth Subsalicylate, 262 mg

Antidiarrheal

Upset Stomach Reliever

Effective Diarrhea Relief

Restores Natural Balance

* Please review the disclaimer below.