Docusate Sodium
FDA Label NDC 16103-384

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 16103-384). 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, 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

  • prevents/relieves dry hard stool
  • results usually occurs 1 to 3 days after the first dose

Do Not Use

  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor

Ask A Doctor Before Use If You

  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last over 2 weeks

Stop Use And Ask A Doctor If

  • you have no bowel movement after 3 days
  • you have rectal bleeding
    • These could be signs of a serious condition

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

  • do not exceed recommended dose
    • adults and children over 12 years                        
    		take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
    children 6 to 12 years
    		take 1 softgel daily
    children under 6 years
    		consult a doctor

Other Information

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature 15o to 30oC (59o to 86oF)
  • protect from moisture

Questions?

Adverse drug event call: (866) 562-2756

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

1000 SOFTGELS

100 mg each

* Please review the disclaimer below.