Docusate Sodium
FDA Label NDC 61919-459

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Direct_rx for the product Docusate Sodium (NDC 61919-459). 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 otc - active ingredient section, otc - purpose section, indications & usage section, warnings section, dosage & administration section, package label.principal display panel, otc - keep out of reach of children section, inactive ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient Section

Docusate Sodium 100 mg

Otc - Purpose Section

Stool softener

Indications & Usage Section

  • for prevention of dry, hard stools
  • for relief of occasional constipation

    • This product generally produces a bowel movement within 12 to 72 hours.

Warnings Section

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor 
  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor 

    • Ask a doctor before use if

    if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

    Stop use and ask a doctor if

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

      • These could be signs of a serious condition.

      If pregnant or breast-feeding,

      ask a health care professional before use.

      Keep out of reach of children.

      In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration Section

Directions

 adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime
 children 6-12 years of age take 1 softgel at bedtime
 children under 6 years ask a doctor

Other information

  • each softgel contains: sodium 6 mg
  • store between 15°-30°C (59°-86°F)

    • Questions or comments?

    1-800-645-2158

    Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN COLACE®*

    NON-HABIT FORMING

    Stool Softener Laxative

    Docusate Sodium USP, 100 mg

    SOFTGEL CAPSULES

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *Rugby Laboratories is not affiliated with the owner of the trademark Colace®.

    Distributed by: Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI  48150

Otc - Keep Out Of Reach Of Children Section

In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredient Section

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

* Please review the disclaimer below.