Docusate Sodium
FDA Label NDC 68210-4104

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Docusate Sodium (NDC 68210-4104). 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 other, active ingredient (in each softgel), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg 

Purpose

Stool Softner

Uses

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Warnings

Ask A Doctor Before Use If You Have

  • stomach pain, nausea or vomittiong
  • a sudden change in bowel habits that lasts more than 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 laxative for more than 1 week.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

    1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

    Children 2 to under 12 years of age

    1 softgel daily.

    Children under 2 years of age

    Ask a doctor

Other Information

  • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed

Inactive Ingredients

FD&C Red#40, FD&C Yellow#6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions Or Comments?

1-888-333-9792

Pdp

Cabinet:
Stool Softener
Docusate Sodium 100mg

75 Softgels

Image Description (Docusate)

Image Description (Docusate)

* Please review the disclaimer below.