NDC 63868-347 Quality Choice

Psyllium Husk

NDC Product Code 63868-347

NDC Code: 63868-347

Proprietary Name: Quality Choice 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: Psyllium Husk 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.

NDC Code Structure

  • 63868 - Quality Choice (chain Drug Marketing Association)
    • 63868-347 - Quality Choice

NDC 63868-347-17

Package Description: 368 g in 1 CANISTER

NDC Product Information

Quality Choice with NDC 63868-347 is a a human over the counter drug product labeled by Quality Choice (chain Drug Marketing Association). The generic name of Quality Choice is psyllium husk. The product's dosage form is powder, for suspension and is administered via oral form.

Labeler Name: Quality Choice (chain Drug Marketing Association)

Dosage Form: Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the 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.

Quality Choice 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.

  • PSYLLIUM HUSK 3.4 g/5.8g

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.

  • ASPARTAME (UNII: Z0H242BBR1)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: part334 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-17-2019 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

Blond Psyllium

Blond Psyllium is


...
[Read More]
Psyllium

Psyllium is pronounced as (sil' i yum)
Why is psyllium medication prescribed?
Psyllium, a bulk-forming laxative, is used to treat constipation. It absorbs liquid in the intestines, swells, and forms a bulky stool, which is easy to pass.This medicat...
[Read More]

* Please review the disclaimer below.

Quality Choice 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

Active Ingredient (In Each Teaspoon)

Psyllium husk approximately 3.4 g

Purpose

Fiber therapy for regularity

Uses

  • •for relief of occasional constipation (irregularity)

Warnings

Allergy alert: This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Ask A Doctor Before Use If You Have

  • •abdominal pain, nausea or vomiting •a sudden change in bowel habits persisting for 2 weeks

Stop Use And Ask A Doctor If

  • •Constipation lasts more than 7 days •Rectal bleeding occursThese may be signs of a serious condition.

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:

Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickness, add more liquid and stir.Adults 12 years & older:1 rounded TEASPOON in 8 oz of liquid at the signs of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.6-11 yrs:½ adult dose in 8 oz of liquid, up to 3 times dailyUnder 6 yrs:Consult a doctorBulk-forming fibers like psyllium husk may affect how well other medicines work. If t=you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary

Other Information

  • •each teaspoon contains: potassium 30 mg and sodium 5 mg •PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon •Store at room temperature tightly closed to protect from humidity •Do not use if printed inner seal is broken or missing •Contains a 100% natural, therapeutic fiber

Inactive Ingredients

Aspartame, citric acid, FD&C yellow 6, maltodextrin, natural and artificial orange flavor, silica.

Fiber Supplement Information

  • Uses: •Daily fiber supplement. Each serving adds 3 grams of fiber to your diet. •For lowering cholesterol to promote heart health. Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering cholesterol. One adults dose of this products has 2.4 grams of this soluble fiber. Consult a doctor if you are considering use of this product as a part of a cholesterol lowering program.Warnings Read entire label, including warnings in Drug Facts.Directions Adults 12 years and older: put 1 rounded TEASPOON in to an empty glass and mix with 8 oz of liquid up to 3 times daily for daily fiber supplement; 3 times daily to help maintain healthy blood sugar levels† and for cholesterol lowering to promote heart health.under 12 years: Consult a doctor.See mixing directions in Drug Facts.NOTICE: Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing. See choking warning.This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels†.

* Please review the disclaimer below.

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