Docusate Sodium
FDA Label NDC 10135-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals Inc for the product Docusate Sodium (NDC 10135-111). 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, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, 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

Active Ingredient (In Each Softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

  • relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Do Not Use

if you are presently taking mineral oil, unless directed to do so by a doctor

Ask A Doctor Before Use If You Have

  • stomach pain
  • Nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop Use And Ask A Doctor If

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.
  • you need to use stool softner laxative for more than 1 week

    • These could be sings 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

adults and children 12 years and overtake 1 - 3 softgels once daily or in divded doses
children 2 to under 12 years of age1 softgel once daily
children under 2 yearsask a doctor

Other Informaiton

  • each softgel contains: sodium 7 mg
  • store at room temperature 15°-25°C (59°-77°F) and avoid excessive heat

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

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

*Marlex Pharmaceuticals, Inc., is not affiliated with the owner of the trademark Colace®

Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720

Made in Romania

Principal Display Panel

NDC 10135-0111-01
Docusate Sodium
100 mg
100 Softgels

Principal Display Panelndc 10135-0111-01docusate Sodium100 mg100 Softgels (Docusate Sodium 01)

Principal Display Panelndc 10135-0111-01docusate Sodium100 mg100 Softgels (Docusate Sodium 01)

Principal Display Panelndc 10135-0111-01docusate Sodium100 mg100 Softgels (Docusate Sodium 02)

Principal Display Panelndc 10135-0111-01docusate Sodium100 mg100 Softgels (Docusate Sodium 02)

* Please review the disclaimer below.