Docusate Sodium Capsule, Liquid Filled
FDA Label NDC 53345-008

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 (NDC 53345-008). 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, 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

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Drug Facts

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

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

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 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

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

Inactive Ingredients

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink

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

Principal Display Panel - Shipping Label

DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 20000 Capsules
NDC. No : 53345-008-01

IMPORTANT:

  • Inspect immediately 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 REPACKAGING

    DOCUSATE SODIUM CAPSULES, 100 mg
    Quantity : 15000 Capsules
    NDC. No : 53345-008-02


    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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