Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Dok
FDA Label NDC 67296-1556
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redpharm Drug, Inc. for the product Dok (NDC 67296-1556). 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, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener laxative
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 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 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.
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
Other Information
each softgel contains: sodium 6 mg
store at 25°C (77°F);excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol
*contains one or more of these ingredients
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Keep Out Of Reach Of Children
Keep out of reach of children.
Principal Display Panel
Docusate (Doc20180323104539 001)
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