Stool Softener
FDA Label NDC 76168-069

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma for the product Stool Softener (NDC 76168-069). 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, purpose, uses, warnings, keep out of reach of children., 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 temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have:

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

    • Ask a doctor or pharmacist before use if you are presently taking mineral oil.

    Stop use and ask a doctor if:

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

      • If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Take with glass of water

adults and children 12 years and over:

  • 1 to 3 liquid gels daily. This dose may be taken as single daily dose or in divided doses.

    Children under 12 years of age:

  • 1 liquid gel daily

    • Children under 2 years of age

    Ask a doctor

Other Information

  • store at 15-30 °C (59-86 °F)
  • protect from excessive humidity
  • do not use this product if the safety seal under the cap is torn or missing

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions Or Comments

Call 1-855-314-1850

Package Label.Principal Display Panel

5d5cb3d5-figure-01 (5d5cb3d5 Figure 01)

5d5cb3d5-figure-01 (5d5cb3d5 Figure 01)

5d5cb3d5-figure-02 (5d5cb3d5 Figure 02)

5d5cb3d5-figure-02 (5d5cb3d5 Figure 02)

NDC: 076168-069-05 – 25 COUNT

* Please review the disclaimer below.