NDC 68163-119 Fiber Laxative

Psyllium Husk

NDC Product Code 68163-119

NDC Code: 68163-119

Proprietary Name: Fiber Laxative 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.

Product Characteristics

Color(s):
BROWN (C48332)
Shape: CAPSULE (C48336)
Size(s):
21 MM
Imprint(s):
RP119
Score: 1

NDC Code Structure

  • 68163 - Raritan Pharmaceuticals Inc
    • 68163-119 - Fiber Laxative

NDC 68163-119-25

Package Description: 25 CAPSULE in 1 BOTTLE

NDC Product Information

Fiber Laxative with NDC 68163-119 is a a human over the counter drug product labeled by Raritan Pharmaceuticals Inc. The generic name of Fiber Laxative is psyllium husk. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Raritan Pharmaceuticals Inc

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

Fiber Laxative 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 .52 g/1

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)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

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: 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.

Fiber Laxative 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 (In Each Capsule)

Psyllium husk approximately 0.52 g

Purpose

Fiber laxative

Uses

  • •effective in treating occasional constipation and restoring regularity

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.

Allergy Alert

  • This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.Ask a doctor before use if you have •a sudden change in bowel habits persisting for 2 weeks •abdominal pain, nausea or vomitingStop 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

  • •Take this product 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. •Adults 12 years and older: 5 capsules with at least 8 ounces. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours •children 12 years and under: Ask a doctor •Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication 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.

Other Information

  • •each capsule contains: potassium 5 mg •store at room temperature. Keep tightly closed to protect from humidity •contains a 100% natural, therapeutic fiberWARNING: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

Inactive Ingredients

Caramel color, edible ink, gelatin, polysorbate 80

* Please review the disclaimer below.

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