Stool Softener Docusate Sodium 50 Mg
FDA Label NDC 69842-072

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Stool Softener Docusate Sodium 50 Mg (NDC 69842-072). 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 and over

take 1 to 6 softgels daily

Children 2 to under 12 years of age

take 1 to 3 softgels daily

children under 2 years

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 - 30 Softgel Carotn

STOOL SOFTENER

NDC 69842-072-20

Compare to the active ingredient in Colace® 50 mg

50 MG DOCUSATE SODIUM PER SOFTGEL

Stimulant free

Gentle & effective

Comfortable relief of constipation

30 Softgels

Principal Display Panel - 100 Softgel Carotn

STOOL SOFTENER

NDC 69842-072-24

Compare to the active ingredient in Colace® 50 mg

50 MG DOCUSATE SODIUM PER SOFTGEL

Stimulant free

Gentle & effective

Comfortable relief of constipation

100 Softgels

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