Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Docusate Sodium
FDA Label NDC 84289-399
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmamed Usa Inc for the product Docusate Sodium (NDC 84289-399). 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 active ingredient (in each softgel), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
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 lasts over 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail to have 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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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)
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 1-3 softgels daily |
| children 2 to under 12 years of age | take 1 softgel daily |
| children under 2 years | ask a doctor |
Other Information
- each softgel contains: sodium 6 mg
- VERY LOW SODIUM
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
keep tightly closed.
Inactive Ingredients
D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide
Questions Or Comments?
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Package Label Principal Display Panel
PHARMAMED
NDC 84289-399-01
Manufactured in the U.S.A
Docusate
Sodium
100 softgels
100mg each
*Compare to the active ingredient of Colace*
THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
* Please review the disclaimer below.
