Fleet

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2021-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:28:25

Label at a glance#

ProductFleet
Active ingredientSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC
Label structure10 sections

Dosage and administration

Single Daily Dosage: Do not use more unless directed by a doctor. See Warnings.    Adults and children 12 years and over  One Bottle  Children 2 to 11 years  Use Fleet Enema for Children  Children under 2 years  DO NOT USE

Label contents#

Full prescribing information#

Active Ingredient (in each 118-mL delivered dose)

OTC - ACTIVE INGREDIENT SECTION

Monobasic Sodium Phosphate 19 g................

Dibasic Sodium Phosphate 7 g........................

Purpose

OTC - PURPOSE SECTION

Laxative / Bowel Cleanser

Laxative / Bowel Cleanser

Use

INDICATIONS & USAGE SECTION

For relief of occasional constipation or bowel cleansing before rectal examinations.

Warnings

WARNINGS SECTION

Using more than one enema in 24 hours can be harmful.

Ask a doctor before using this product if you

OTC - ASK DOCTOR SECTION

  • are on a sodium-restricted diet
  • have kidney disease are pregnant or nursing a baby

Ask a doctor before using any laxative if you:

OTC - ASK DOCTOR SECTION

  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasting more than 2 weeks
  • have already used a laxative for more than 1 week

Stop using this product and consult a doctor if you

OTC - STOP USE SECTION

  • have rectal bleeding
  • have no bowel movement after the enema is given

These symptoms may indicate a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or accidental ingestion, get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Single Daily Dosage: Do not use more unless directed by a doctor. See Warnings.  
 Adults and children 12 years and over One Bottle
 Children 2 to 11 years Use Fleet Enema for Children
 Children under 2 years DO NOT USE

Other Information

OTHER SAFETY INFORMATION

Sodium Content 4.4 g

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium EDTA, purified water

Questions?

OTC - QUESTIONS SECTION

C.B. Fleet Co., Inc.

Lynchburg, VA 24502

U.S.A.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fleet
SODIUM PHOSPHATES
ENEMA USP
FOR RELIEF OF CONSTIPATION
ACTS WITHIN MINUTES
REGULAR
130 ml

Fleet SODIUM PHOSPHATES ENEMA USP FOR RELIEF OF CONSTIPATION ACTS WITHIN MINUTES REGULAR 130 mlFleet SODIUM PHOSPHATES ENEMA USP FOR RELIEF OF CONSTIPATION ACTS WITHIN MINUTES REGULAR 130 ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0132-0554-402021-11-10C16284748780-19d75b9d0-e245-f424-e053-dadaa90a57ceFleet Enema Adult Canada 0132-0554-40
0132-0554-402020-01-31C16284748780-19d75b9d0-e245-f424-e053-dadaa90a57ceFleet Enema Adult Canada 0132-0554-40

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-05540132-0554-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
21da3eaa-aa33-40e9-8b91-9ce19783996c87a3e05e-d02f-40d7-af82-eb50bf669b962024-10-11WarningsExact identifier
spl set id: 87a3e05e-d02f-40d7-af82-eb50bf669b96

Reported adverse events (FAERS/openFDA)#

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