Fleet

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2024-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:14:13

Label at a glance#

ProductFleet
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Dosage and administration

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 1-3 softgels daily Children 2 to under 12 years of age take 1 softgel daily Children under 2 years ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if you are presently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-866-255-6960

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fleet

Docusate sodium 100 mg Stool Softener

Oral Laxative

25 softgels

Principal Display Panel Fleet Docusate sodium 100 mg Stool Softener Oral Laxative 25 softgelsPrincipal Display Panel Fleet Docusate sodium 100 mg Stool Softener Oral Laxative 25 softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2
1115005docusate sodium 100 MG Oral CapsuleSCD2
1115005DOSS Sodium 100 MG Oral CapsuleSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0402-25Fleet25 in 1 BOTTLECAPSULE, LIQUID FILLED252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0402FLEET (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [C.B. FLEET COMPANY, INC.]2Current NDC, 1 package rows20240627_56a7b6c5-d674-4eed-91c2-77f7d18fff32.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-04020132-0402-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FleetDOCUSATE SODIUMC.B. Fleet Company, Inc.56a7b6c5-d674-4eed-91c2-77f7d18fff322024-06-27WarningsExact identifier
ndc (package): 0132-0402-25
ndc (product): 0132-0402
ndc11 (package): 00132040225
spl id: 9f60cac9-8c8b-41b0-964b-b30d15e8f808
spl set id: 56a7b6c5-d674-4eed-91c2-77f7d18fff32

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.