Fleet Capsule, Liquid Filled
FDA Label NDC 0132-0402

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Fleet (NDC 0132-0402). 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 (in each softgel), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., 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

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 directed by a doctor

Ask A Doctor Before Use If You Have

  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over a period of 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 symptoms may indicate a serious condition.
  • you need to use a stool softener 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
    • Adults and children 12 years and overtake 1-3 softgels daily
    Children 2 to under 12 years of agetake 1 softgel daily
    Children under 2 yearsask a doctor

Other Information

  • each softgel contains: sodium 5 mg
  • VERY LOW SODIUM
  • store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

Inactive Ingredients

black edible ink, citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol solution, water

Questions?

Call 1-866-255-6960

Principal Display Panel

Fleet

Docusate sodium 100 mg Stool Softener

Oral Laxative

25 softgels

Principal Display Panel Fleetdocusate Sodium 100 mg Stool Softeneroral Laxative25 Softgels (Fleet Oral Lax Docusate Sodium 0132 0402 01)

Principal Display Panel Fleetdocusate Sodium 100 mg Stool Softeneroral Laxative25 Softgels (Fleet Oral Lax Docusate Sodium 0132 0402 01)

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