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Drug Facts
Stool Softener Capsule, Liquid Filled
FDA Label NDC 51013-819
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Stool Softener (NDC 51013-819). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each softgel), purpose, use, warnings, otc - do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Purpose
Stool softener laxative
Use
- for relief of occasional constipation and irregularity.
- This product generally produces bowel movement in 12 to 72 hours.
Warnings
Otc - Do Not Use
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 or vomiting
- a sudden change in bowel habits that lasts more than 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
In case of overdose, get medical help or contact a Posion Control Center right away.
Directions
- take with a glass of water -see Overdose warning
adults and children 12 years of age and over | 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses |
| children 2 to under 12 years of age | 1 softgel daily |
| children under 2 years of age | ask a doctor |
Other Information
- each softgel contains: sodium 5mg
- store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity
- contains FD&C Yellow No. 6
Inactive Ingredients
citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, purified water and white edible ink
Questions Or Comments?
Call toll free: 1-855-215-8180
Package Label.Principal Display Panel
PuraVation Stool Softener
Docusate Sodium - 100 mg EACH
100 SOFTGELS
NDC 51013-819-01
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