Docusate Sodium 100mg Two-tone Capsule, Liquid Filled
FDA Label NDC 53345-023

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 100mg Two-tone (NDC 53345-023). 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, 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.

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Drug Facts

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg

Purpose

Stool softener 

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a 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

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 and over		 take 1 to 3 softgels daily
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years ask a doctor

Other Information

  • each softgel contains: sodium 5 mg
  • VERY LOW SODIUM
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients

Black ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and purified water


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

Principal Display Panel - Shipping Label

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 15000 Capsules
NDC. No : 53345-023-02

IMPORTANT:

  • Inspect immediate upon receipt.
  • This is a bulk shipment, intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • Store at 15-30°C (59-86°F)

    • CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

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