NDC 68163-571 Natural Orange Flavor Organic Natural Fiber

Psyllium Husk

NDC Product Code 68163-571

NDC CODE: 68163-571

Proprietary Name: Natural Orange Flavor Organic Natural Fiber 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat constipation. It increases the bulk in your stool, an effect that helps to cause movement of the intestines. It also works by increasing the amount of water in the stool, making the stool softer and easier to pass. Psyllium, one type of bulk-forming laxative, has also been used along with a proper diet to treat high cholesterol.

NDC Code Structure

  • 68163 - Raritan Pharmaceuticals Inc

NDC 68163-571-72

Package Description: 864 g in 1 CANISTER

NDC Product Information

Natural Orange Flavor Organic Natural Fiber with NDC 68163-571 is a a human over the counter drug product labeled by Raritan Pharmaceuticals Inc. The generic name of Natural Orange Flavor Organic Natural Fiber is psyllium husk. The product's dosage form is powder and is administered via oral form.

Labeler Name: Raritan Pharmaceuticals Inc

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Natural Orange Flavor Organic Natural Fiber 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/12g

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • RAW SUGAR (UNII: 8M707QY5GH)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Raritan Pharmaceuticals Inc
Labeler Code: 68163
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: 03-20-2019 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: 12-31-2021 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 - NO 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

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]
Black Psyllium

Black Psyllium is

...
[Read More]
Blond Psyllium

Blond Psyllium is

...
[Read More]

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Natural Orange Flavor Organic Natural Fiber Product Label Images

Natural Orange Flavor Organic Natural Fiber 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 Tablespoon)

Psyllium Hydrophilic Mucilloid 3.4g

Purpose

Fiber therapy for regularity

Use

For relief of occasional constipation (regularity)

Warnings

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

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

Stop Use And Ask A Doctor

  • ▪constipation lasts more than 7 days▪rectal bleeding occursThese may be sings 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 oz (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 TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours. Children under 12 yrs: Consult a doctor before useBulk-forming fibers like psyllium husk may affect how well other medicines work. If 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 increase fiber intake, you may experience changes in bowel habits or minor bloating.New Users: Start with 1 serving per day, gradually increase to desired daily intake. You may initially experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake.

Other Information

  • ▪each tablespoon contains: potassium 35 mg; sodium 5 mg▪Store at room temperature tightly closed to protect from humidity▪Do not use if printed seal under cap is torn or missing▪Contains a 100% natural, therapeutic fiber‡Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from fiber such as NuSyllium may reduce the risk of heart disease by lowering cholesterol.*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Inactive Ingredients

Natural citric acid, natural flavors, Organic Brown Cane Sugar, Organic Vegetable Glycerin.

* Please review the disclaimer below.