Best Choice Fiber Therapy
Methylcellulose
Best Choice (valu Merchandisers Company)
Human Otc Drug
NDC 63941-122Best Choice Fiber Therapy also known as Methylcellulose is a human otc drug labeled by 'Best Choice (valu Merchandisers Company)'. National Drug Code (NDC) number for Best Choice Fiber Therapy is 63941-122. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Best Choice Fiber Therapy drug includes Methylcellulose (4000 Mpa.s) - 500 mg/1 . The currest status of Best Choice Fiber Therapy drug is Active.
Drug Information:
| Drug NDC: | 63941-122 |
| 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: | Best Choice Fiber Therapy |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Best Choice |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Fiber Therapy |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Best Choice (valu Merchandisers Company) |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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) - 500 mg/1
|
| 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: | 19 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: | BEST CHOICE (VALU MERCHANDISERS COMPANY)
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198750
|
| 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. |
| UPC: | 0070038607410
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 63941-122-10 | 100 TABLET in 1 BOTTLE (63941-122-10) | 19 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:
Best choice fiber therapy methylcellulose methylcellulose (4000 mpa.s) methylcellulose (4000 mpa.s) adipic acid calcium carbonate crospovidone (120 .mu.m) fd&c yellow no. 6 magnesium stearate microcrystalline cellulose polysorbate 80 silicon dioxide light orange caplet rp122
Indications and Usage:
Uses ? relieves occasional constipation (irregularity) ? generally produces a bowel movement 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 ? a sudden change in bowel habits that persists over a period of 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.
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 over a period of 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 take 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. age dose maximum dose adults & children 12 years of age and over start with 2 caplets. increase as needed up to 6 times per day. do not exceed 12 caplets per day children 6-11 years of age start with 1 caplet. increase as needed up to 6 times per day do not exceed 6 caplets per day children under 6 years of age consult a physician 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. 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.
Package Label Principal Display Panel:
Principal display panel best choice ® ndc# 63941-122-10 compare to the active ingredients in citrucel ® caplets* fiber therapy methylcellulose fiber capsules for regularity 100% soluble fiber for controlled regularity easy to take caplets nan 100 caplets best choice 100% guaranteed www.bestchoicebrand.com proudly distributed by: valu merchandisers, co. 5000 kansas ave kansas city, ks 66106 *this product is not manufactured or distributed by glaxosmithkline, the distributor owner of the registered trademark citrucel ® caplets. when used as directed. based on laboratory testing. individual results may vary. best choice best choice fiber therapy 100 chewable tablets
Further Questions:
Questions or comments? 1-866-467-2748