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Drug Facts
Docusate Sodium Softgels 50mg (dye Free) Capsule, Liquid Filled
FDA Label NDC 51316-652
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Docusate Sodium Softgels 50mg (dye Free) (NDC 51316-652). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each softgel)
Docusate sodium USP 50 mg
Otc - Purpose
Purpose
Stool softener
Indications & Usage
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Warnings
Otc - Do Not Use
Do not use
- if you are presently taking mineral oil, unless told to do so by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Otc - Stop Use
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 signs of a serious condition.
- you need to use a stool softener 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage & Administration
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 1-6 softgels daily |
children 2 to under 12 years of age | take 1-3 softgels daily |
children under 2 years | ask a doctor |
Other Safety Information
Other information
- each softgel contains: sodium 3 mg VERY LOW SODIUM
- Keep tightly closed. Store at 25°C (77°F); excursions permitted between 15°-30°C (59-86°F)
Inactive Ingredient
Inactive ingredients ferrosoferric oxide, gelatin, glycerin, polyethylene glycol, propylene glycol, noncrystallizing sorbitol solution, purified water, shellac
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
652t_30ct_ifc (652t 30ct Ifc)
652t_30ct_lbl (652t 30ct Lbl)
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