Docusate Sodium Capsule
FDA Label NDC 16103-399

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals, Inc. for the product Docusate Sodium (NDC 16103-399). 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

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg

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 agetake 1 softgel daily
    children under 2 yearsask a doctor

Other Information

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • each softgel contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF).

    • 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?

Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PM

Package Label.Principal Display Panel

NDC 16103-0399-11

PHARBEST

*Compare to the active ingredient of Colace®

Docusate

Sodium

Stool Softener

1000 SOFTGELS

100 mg each

* Please review the disclaimer below.