Gentle Relief Stool Softner
Gentle Relief Stool Softnet
Healthlife Of Usa
Human Otc Drug
NDC 69517-124Gentle Relief Stool Softner also known as Gentle Relief Stool Softnet is a human otc drug labeled by 'Healthlife Of Usa'. National Drug Code (NDC) number for Gentle Relief Stool Softner is 69517-124. This drug is available in dosage form of Capsule, Gelatin Coated. The names of the active, medicinal ingredients in Gentle Relief Stool Softner drug includes Docusate Sodium - 100 mg/1 . The currest status of Gentle Relief Stool Softner drug is Active.
Drug Information:
| Drug NDC: | 69517-124 |
| 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: | Gentle Relief Stool Softner |
| 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: | Gentle Relief Stool Softnet |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Healthlife Of Usa |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Gelatin Coated |
| 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: | DOCUSATE SODIUM - 100 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: | 31 May, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Jun, 2026 |
| 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, 2024 |
| 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: | Healthlife of USA
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | F05Q2T2JA0
|
| 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 |
|---|
| 69517-124-24 | 1 BOTTLE in 1 CARTON (69517-124-24) / 24 CAPSULE, GELATIN COATED in 1 BOTTLE | 31 May, 2017 | 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:
Drug facts gentle relief stool softner
Purpose stool softner
Product Elements:
Gentle relief stool softner gentle relief stool softnet fd&c yellow no. 6 gelatin sorbitol titanium dioxide fd&c red no. 40 glycerin polyethylene glycol 400 propylene glycol water docusate sodium docusate
Indications and Usage:
Uses for prevention of dry, hard stools for relief of occasional constipation. this product generally produces a bowel movement within 12 to 72 hours
Warnings:
Warnings do not use if you are presently taking mineral oil, unless directed by a doctor when abdominal pain, nausea, or vomiting are present for longer than 1 week, unless directed by a doctor
Dosage and Administration:
Directions take with a glass of water adults and children 12 years of age and over: take 1 to 3 softgels daily. this dose may be taken as single daily dose or in divided doses children 2 to under 12 years of age: take 1 softgel daily children under 2 years of age: consult a physician
Stop Use:
Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use
Package Label Principal Display Panel:
Gentle relief stool softner docusate sodium 100mg gentle and easy relief of constipation 24 softgels distributed by: healthlife of usa llc rahway nj 07065 www.healthlifeofusa.com compare to dulcolax® stool softner active ingredients image description
Further Questions:
Other information each softgel contains sodium 6 mg store at controlled room temperature 15°-30°c (59°-86°f) read all product information before using tamper evident: do not use if imprinted safety seal under cap is broken or missing
Questions or comments? call toll free 1-844-832-1138 monday through friday 9am - 5pm est or www.healthlifeofusa.com