Docusate Sodium
FDA Label NDC 68210-0350

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 68210-0350). 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 gelcaps), purpose, uses, do not use, ask a doctor before use if you, stop use abd ask a doctor if you, if pregnant 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 Gelcaps)

Docusate Sodium 100 mg 

Purpose

Stool Softner

Uses

  • for the prevention of the dry, hard stools
  • for relief of occassional constipation. This product generally produces a bowel movement within 12 to 72 hours

Do Not Use

if you are currently taking mineral oil, unless directed to so 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 You

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

Stop Use Abd Ask A Doctor If You

have rectal bleeding fail to have a bowel movement occur after use.

If Pregnant Or Breast-Feeding

ask a health professional before use

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center 1(800)222-1222 immediately.

Stop Use And Ask A Doctor If You

have rectal bleeding fail to have bowel movement occur after use.

If Pregnant Or Breast Feeding

Ask a health professional before use 

Keep Out Of Reach Of Children

In case of accidental overdose, get medical help or contact a Poison Control Center 1-800-222-1222 immediately.

Directions

  • adult and children 12 years and over: take 1-3 gelcaps, preferably at bedtime
    • children 2 to under 12 years of age: take 1 gelcap at bedtime
    • children under 2 years of age: ask a doctor

Other Information

  • Store at room temperature 15-30°C  (59-86°F) 
  • do not use if safety seal under cap is torn or missing

Inactive Ingredients

FD&C Red #33, FD&C Red#40, FD&C Yellow#6, gelatin,

glycerin, polyethylene glycol 400, propylene glycol, purified

water, shellac, sorbitol solution, titanium dioxide.

Questions Or Comments?

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Compare to the active ingredient in

Colace ® Gel Caps *

STOOL

SOFTENER

DOCUSATE SODIUM 100 mg

Gentle
Effective
Stimulant-Free Relief
100 GELCAPS

* Please review the disclaimer below.