NDC 63868-339 Qc Anti Diarrheal Vanilla Regular Flavor

Bismuth Subsalicylate

NDC Product Code 63868-339

NDC Code: 63868-339

Proprietary Name: Qc Anti Diarrheal Vanilla Regular Flavor 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.

Non-Proprietary Name: Bismuth Subsalicylate 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.


Code Structure
  • 63868 - Quality Choice (chain Drug Marketing Association)
    • 63868-339 - Qc Anti Diarrheal

NDC 63868-339-12

Package Description: 355 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Qc Anti Diarrheal Vanilla Regular Flavor with NDC 63868-339 is a 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.

Labeler Name: Quality Choice (chain Drug Marketing Association)

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug 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.


Qc Anti Diarrheal Vanilla Regular Flavor Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BISMUTH SUBSALICYLATE 262 mg/15mL

Inactive Ingredient(s)

About the 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.

  • CARAMEL (UNII: T9D99G2B1R)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SUCROSE (UNII: C151H8M554)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.

Labeler Name: Quality Choice (chain Drug Marketing Association)
Labeler Code: 63868
FDA Application Number: part335 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 04-16-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

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 Images

Qc Anti Diarrheal Vanilla Regular Flavor Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

* Please review the disclaimer below.

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