Docusate Sodium 50 Mg Capsule, Liquid Filled
FDA Label NDC 53345-015

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceutical (wuhan), Ltd. for the product Docusate Sodium 50 Mg (NDC 53345-015). 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, do not use, ask a doctor before use if you have, stop use and ask a doctor if, directions, 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 50 mg

Purpose

Stool softener

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 told 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

Stop Use And Ask A Doctor If

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

Directions

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

Adults and children 12 years of ages and over

take 1 to 6 softgels daily

Children 2 and under 12 years of age

take 1 to 3 softgels daily

children under 2 years of age

ask a doctor

Other Information

  • each softgel contains: sodium 3 mg VERY LOW SODIUM
  • store at 15°-30°C (59°-86°F)

    Keep tightly closed.

Inactive Ingredients

citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

Principal Display Panel - Shipping Label

 

DOCUSATE SODIUM CAPSULES, 50 mg

Quantity : 20000 Capsules
NDC. No : 53345-015-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

 

* Please review the disclaimer below.