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| Product NDC Code | 24689-130 | ||||
|---|---|---|---|---|---|
| Drug Name | Docusate sodium |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1115005 | ||||
| Application Number | M007 | ||||
| Labeler Name | APNAR PHARMA LP | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (In each softgel) Docusate Sodium.... 100 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over : take 1 to 3 softgels daily children 2 to under 12 years of age : take 1 softgel daily children under 2 years : ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White Ink
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Purpose
Information about the drug product’s indications for use.Purpose Stool softener laxative
Spl product data elements
Usually a list of ingredients in a drug product.Docusate sodium Docusate sodium GELATIN GLYCERIN SORBITOL DOCUSATE SODIUM DOCUSATE SORBITAN WATER FD&C RED NO. 40 FD&C YELLOW NO. 6 Oblong AD2
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.NDC 24689-130-01 Docusate Sodium 100mg Stool Softener Laxative MADE IN USA 100 Softgels Docusate Sodium Softgel lable-100mg
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Compare to the active ingredient in Colace® Regular Strength Stool Softener† †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener. Rev.: 03/2023 Manufactured by: Apnar Pharma LLP East Windsor, NJ 08520
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments ? Call 1-855-642-2594
Storage and handling
Information about safe storage and handling of the drug product.Other Information each softgel contains: sodium 5 mg store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that last over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition. you need to use a stool softner laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API