Docusate Sodium
FDA Label NDC 68210-0317

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 68210-0317). 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 softgel), purpose, uses, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, stop use and ask a doctor if you, 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 Softgel)

Docusate Sodium 100 mg 

Purpose

Stool Softner laxative

Uses

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Warnings

Ask A Doctor Before Use If You Have

  • stomach pain, nausea or vomittiong
  •  a sudden change in bowel habits that lasts more than 2 weeks

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop Use And Ask A Doctor If You

  • you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
  • yo need to use laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Directions

take with a glass of water

Adults and children 12 years and over

1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

Children 2 to under 12 years of age

1 softgel daily.

Children under 2 years of age

Ask a doctor

Other Information

  • Store at room temperature 20-25°C  (68-77°F) 
  • protect from excessive humidity
  • do not use this product of the safety seal under the cap is torn or missing

Inactive Ingredients

FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions Or Comments?

1-888-333-9792

Principal Display Panel- Valumeds Stool Softener 30 Softels Bottle Labels-Single Tone

VALUMEDS TM

Compare to the active ingredient in

Dulcolax  ® Stool Softener  *

STOOL  SOFTENER

DOCUSATE SODIUM 100 mg

Gentle,Stimulant-Free Relief
Constipation Relief

30 SOFTGELS

* Please review the disclaimer below.