Docusate Sodium
FDA Label NDC 73147-8273

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cellchem Pharmaceutical Inc for the product Docusate Sodium (NDC 73147-8273). 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 capsule)                         purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Capsule)                         Purpose

Docusate sodium 100 mg................................................Laxative, stool softener

Uses

  • Relief of occasional constipation 
  • softens the stools

Warnings


Do Not Use

  • if you have
    • abdominal pain
    • nausea
    • fever
    • vomiting
    • with other medicines or if you are presently taking mineral oil
    • if you are on a low salt diet
    • longer than 7 days

When Using This Product

  • frequent or prolonged use may result in dependence on laxatives
  • it may take up to 3 days for you to have a bowel movement

Stop Use And Ask A Doctor If

  • rectal bleeding occurs
  • symptoms persist, last for more than 7 days

Directions

  • Adults and children 12 years and over: 
  • Take 1 - 2 capsules daily or as directed by physician 
  • Do not take more than 4 capsules per day.
  • Drink lots of fluids (one full glass or more)

Other Information

  • Questions ?

    • 1(844) 481-8884

Inactive Ingredients

Polyethylene glycol 400, propylene glycol, gelatin, glycerin, sodium methyl paraben, sodium propyl paraben, sorbitol sorbitan solution, purified water, FD&C Red No. 40, FD&C Yellow No. 6.

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