Heb Fiber Therapy
Methylcellulose
Heb
Human Otc Drug
NDC 37808-716Heb Fiber Therapy also known as Methylcellulose is a human otc drug labeled by 'Heb'. National Drug Code (NDC) number for Heb Fiber Therapy is 37808-716. This drug is available in dosage form of Powder, For Solution. The names of the active, medicinal ingredients in Heb Fiber Therapy drug includes Methylcellulose (4000 Mpa.s) - 2 g/10.2g . The currest status of Heb Fiber Therapy drug is Active.
Drug Information:
| Drug NDC: | 37808-716 |
| 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: | Heb 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: | Heb |
| 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/10.2g
|
| 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: | 25 Apr, 2019 |
| 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: | HEB
|
| 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 |
|---|
| 37808-716-16 | 479 g in 1 BOTTLE, PLASTIC (37808-716-16) | 25 Apr, 2019 | 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:
Heb fiber therapy methylcellulose methylcellulose (4000 mpa.s) methylcellulose (4000 mpa.s) anhydrous citric acid fd&c yellow no. 6 maltodextrin potassium citrate silicon dioxide sucralose tricalcium phosphate
Indications and Usage:
Uses ? relieves constipation (irregularity) ? generally produces a bowel movement 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 ? a sudden change in bowel habits that persists for two weeks ? abdominal pain, nausea or vomiting stop use and ask a doctor if ? constipation lasts more than 7 days ? you have rectal bleeding 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.
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 12 years of age and over start with 1 heaping tablespoon . increase as needed, 1 heaping tablespoon at a time, up to 3 times per day. children 6 - 11 years of age start with 2.5 level teaspoons . increase as needed, 2.5 level teaspoons at a time, up to 3 times per day. children under 6 years of age consult a physician
Stop Use:
Stop use and ask a doctor if ? constipation lasts more than 7 days ? you have rectal bleeding these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel heb ® compare to the active ingredient in citrucel ® powder* ndc 37808-716-16 fiber methylcellulose fiber therapy gentle and clinically proven effective** gives you additional fiber to help balance your diet wont cause excess gas** sugar free orange flavor naturally & artificially flavored net wt 16.9 oz (1.06 lb) (479g) directions for use: 1. fill glass with at least 8 ounces of cold water. 2. add the recommended dose listed in directions. 3. stir briskly until dissolved completely and drink promptly .drinking an additional glass of water is helpful. tamper evident: do not use printed inner seal is broken or missing gluten free *this product is not manufactured or distributed by glaxosmithkline, the distributor of citrucel ® . made with pride & care for h-e-b san antonio, tx 78204 100% guarantee promise if you arent completely pleased with this product, well be happy to replace it or refund your money. you have our word on it. heb fiber therepy methycellulose
Further Questions:
Questions or comments? 1-866-467-2748