Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Docusate Sodium Capsule
FDA Label NDC 81877-840
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Forreal Pharmaceuticals, Llc for the product Docusate Sodium (NDC 81877-840). 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 uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., directions:, other information, package label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Do not use if you are currently taking mineral oil, unless told to do so by a doctor
Ask A Doctor Before Use If You Have
- stomach pain, nausea or 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 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
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center immediately 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 of age | ask a doctor |
Other Information
- each capsule 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.
Package Label Principal Display Panel
NDC 81877-840-90
Forreal Pharmaceuticals LLC
YOUR SOLUTION TO BETTER HEALTHCARE.
Docusate
Sodium
Stool Softener
100 mg
90 Softgels
TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.
Marketed By:
Forreal Pharmaceuticals, LLC
Royal Oak MI 48067
Questions or inquiries call
877-367-3250
Label Image (Docusatesodium 01)
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