Otc - Active Ingredient Section
Docusate sodium 100 mg
Docusate Sodium
FDA Label NDC 61919-888
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Direct Rx for the product Docusate Sodium (NDC 61919-888). 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 otc - active ingredient section, otc - purpose section, indications & usage section, otc - do not use section, otc - ask doctor section, otc - stop use section, otc - pregnancy or breast feeding section, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose Section
Stool softener
Indications & Usage Section
relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours
Otc - Do Not Use Section
Do not use if you are presently taking mineral oil, unless told to do so by a doctor
Otc - Ask Doctor Section
stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks
Otc - Stop Use Section
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 laxative for more than 1 week
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children Section
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration Section
doses may be taken as a single daily dose or in divided doses
Other Safety Information
each softgel contains: sodium 5 mg VERY LOW SODIUM
store at 15°-30°C (59°-86°F)
keep tightly closed
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
Inactive Ingredient Section
FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special
Other
Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811
R0 07/2011
015021CPR
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