Docusate Sodium
FDA Label NDC 66424-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sda Laboratories, Inc. for the product Docusate Sodium (NDC 66424-030). 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, do not use, 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

Do Not Use

If you are currently taking mineral oil, unless directed by a doctor

Ask A Doctor Before Use If You Have

  • stomach pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop Use And Ask A Doctor If

  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • 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.

Directions

  • 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 capsule contains sodium 6 mg
  • store at room temperature 15o-30oC (59o-86oF)
  • Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

Questions?

Adverse drug event call (800) 687-0176

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