NDC 72988-0010 Laxatives Rubilax

Psyllium Huskpowder

NDC Product Code 72988-0010

NDC Code: 72988-0010

Proprietary Name: Laxatives Rubilax 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 Huskpowder 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

  • 72988 - Lydia Co., Ltd.
    • 72988-0010 - Laxatives Rubilax

NDC 72988-0010-2

Package Description: 30 POUCH in 1 POUCH > 3.5 g in 1 POUCH (72988-0010-1)

NDC Product Information

Laxatives Rubilax with NDC 72988-0010 is a a human over the counter drug product labeled by Lydia Co., Ltd.. The generic name of Laxatives Rubilax is psyllium huskpowder. The product's dosage form is granule and is administered via oral form.

Labeler Name: Lydia Co., Ltd.

Dosage Form: Granule - A small particle or grain.

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.

Laxatives Rubilax 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 2168 mg/3.5g
  • SENNA PODS 496 mg/3.5g

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.

  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

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: Lydia Co., Ltd.
Labeler Code: 72988
Marketing Category: UNAPPROVED DRUG OTHER - 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: 04-22-2019 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.

Laxatives Rubilax Product Label Images

Laxatives Rubilax 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

Otc - Active Ingredient

Psyllium husk powder, sennae fructus powder

Inactive Ingredient

Lactose monohydrate, acacia, corn starch, carboxymethylcellulose calcium, l-menthol

Otc - Purpose

Constipationrelieving the following symptoms of constipation: loss of appetite, abdominal distension, intestinal fermentation, hemorrhoids

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Adults take intake does of 3.5g twice a day morning and evening on an empty stomach, however, taking the minimum amount of the first time and watching the shape and condition of the stomach gradually increases or decreases

Warnings

Do not administer to the following patients, the product contains lactose, patients with rare hereditary problems of galactose intolerance, the lapp deficiency or glucose-galactose malabsorption should not take this medicine

Dosage & Administration

For oral use only

* Please review the disclaimer below.

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