Stool Softener
FDA Label NDC 51013-433

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Stool Softener (NDC 51013-433). 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, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, inactive ingredients, 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

  • for relief of occasional constipation (irregularity)
  • this product generally produces a bowel movement in 12 to 72 hours

Ask A Doctor Before Use If You Have

  • stomach pain, nausea, or vomiting
  • a sudden change in bowel habits that lasts over 14 days

Stop Use And Ask A Doctor If

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

Directions

take softgels with a full glass (8oz) of water

adults and children 12 years and older

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

children 6 to under 12 years 

     take 1 softgel daily or as directed by a doctor

children under 6 years 

     ask a doctor

Other Information

  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F) 
  • protect from excessive humidity

Inactive Ingredients

anhydrous citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Stool Softener 

DOCUSATE SODIUM 100 mg  30 SOFTGELS

Compare to Phillips' Stool Softener Liquid Gels active ingredient

NDC 51013-433-20

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