NDC 68788-7995 Fiber Therapy

Methylcellulose

NDC Product Code 68788-7995

NDC CODE: 68788-7995

Proprietary Name: Fiber Therapy 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: Methylcellulose 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):
ORANGE (C48331)
Flavor(s):
ORANGE (C73406)

NDC Code Structure

  • 68788 - Preferred Pharmaceuticals Inc.

NDC 68788-7995-4

Package Description: 454 g in 1 BOTTLE

NDC Product Information

Fiber Therapy with NDC 68788-7995 is a a human over the counter drug product labeled by Preferred Pharmaceuticals Inc.. The generic name of Fiber Therapy is methylcellulose. The product's dosage form is powder, for solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1868843.

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

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 Therapy 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.


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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCROSE (UNII: C151H8M554)

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: Preferred Pharmaceuticals Inc.
Labeler Code: 68788
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: 08-09-2021 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: 12-31-2022 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Fiber Therapy 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 19G Adult Dose/ Rounded Tablespoon)

Methylcellulose 2g (a non-allergenic fiber)

Purpose

Bulk-forming fiber laxative

Uses

  • •relieves constipation (irregularity) •helps to restore and maintain regularity •for treating bowel disorders when recommended by a doctor •generally provide effect in 12-72 hours

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

  • •abdominal pain, nausea or vomiting •a sudden change in bowel habits that persists over a period of 2 weeks •sensitivity to any of the ingredients

Stop Use And Ask A Doctor If

  • •you have rectal bleeding •you fail to have a bowl movement after use. •These could 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.

When Using This Product

  • •do not exceed recommended maximum daily dose unless directed by a doctor •do not use laxative products for a period longer than one week unless directed by a doctor

Directions

  • •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 •use product at the first sign of constipation or irregularity •put one dose in a full glass of cold water •stir briskly and drink promptly •drinking another glass of water is helpfulAgeDoseadults & children above 12 years of age and overone rounded tablespoon. (19 g) in 8 ounces of water fluid up to 3 times daily at the first sign of constipation or irregularitychildren 6 - 12 years of agehalf the adult dose in 8 ounces of water once daily.children under 6 years of ageask a doctor

Other Information

  • •each adult dose contains approximately •3 mg of sodium •105 mg potassium •contributes 60 calories from sucrose and sorbitol •store at room temperature •protect contents from humidity •keep tightly closed TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Inactive Ingredients

Citric acid, FD&C yellow 6 aluminum lake, maltodextrin, flavor (natural and artificial), potassium citrate, silica, sucrose,

* Please review the disclaimer below.