Fiber Therapy
Methylcellulose
Major Pharmaceuticals
Human Otc Drug
NDC 0904-5675Fiber Therapy also known as Methylcellulose is a human otc drug labeled by 'Major Pharmaceuticals'. National Drug Code (NDC) number for Fiber Therapy is 0904-5675. This drug is available in dosage form of Powder, For Solution. The names of the active, medicinal ingredients in Fiber Therapy drug includes Methylcellulose (4000 Mpa.s) - 2 g/19g . The currest status of Fiber Therapy drug is Active.
Drug Information:
| Drug NDC: | 0904-5675 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Fiber Therapy |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Methylcellulose |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Major Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder, For Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | METHYLCELLULOSE (4000 MPA.S) - 2 g/19g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 18 Apr, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part334 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Major Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1868843
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | MRJ667KA5E
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0904-5675-16 | 454 g in 1 BOTTLE (0904-5675-16) | 18 Apr, 2008 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose bulk-forming fiber laxative
Product Elements:
Fiber therapy methylcellulose methylcellulose (4000 mpa.s) methylcellulose (4000 mpa.s) citric acid monohydrate fd&c yellow no. 6 potassium citrate riboflavin sucrose silicon dioxide sorbitol talc
Boxed Warning:
Tamper evident package do not use if printed seal under cap is torn or missing.
Indications and Usage:
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:
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 direct
Read more...ed by a doctor
Dosage and Administration:
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 helpful age dose adults & children above 12 years of age and over one rounded tablespoon. (19 g) in 8 ounces of water fluid up to 3 times daily at the first sign of constipation or irregularity children 6 - 12 years of age children under 6 years of age half the adult dose in 8 ounces of water once daily. ask a doctor
Stop Use:
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.
Package Label Principal Display Panel:
Principal display panel ndc 0904-5675-16 fiber therapy methylcellulose easy to mix no gritty texture 100% soluble fiber for controlled regularity orange flavor net wt 16 oz (454 grams) fiber therapy
Further Questions:
Questions or comments? call toll-free 1-800-616-2471 *this product is not manufactured or distributed by glaxosmithkline the distributor of citrucel® distributed by: major ® pharmaceuticals 17177 n laurel park drive, suite 233 livonia, mi 48152, usa directions for use 1. fill glass with at least 8 ounces of cold water. 2. add the adult or child dose listed in the directions. 3. stir briskly until dissolved and drink promptly. drinking an additional glass of water is helpful. tamper evident package do not use if printed seal under cap is torn or missing. image of pouring water into glass image of stirring water after adding citrucel