Fleet for Children

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2021-04-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:45:52

Label at a glance#

ProductFleet for Children
Active ingredientSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC
Label structure13 sections

Dosage and administration

Single Daily Dosage Do not use more unless directed by a doctor. See Warnings   children 5 to 11 years  One bottle or as directed by a doctor  children 2 to under 5 years  one-half bottle (see below)  children under 2 years  DO NOT USE One-half bottle prepararation:Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow DIRECTIONS on back of carton.  

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient (in each 59-mL delivered dose)

OTC - ACTIVE INGREDIENT SECTION

Monobasic Sodium Phosphate 9.5 g.................Laxative / Bowel Cleanser

Dibasic Sodium Phosphate 3.5 g......................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 the child

OTC - ASK DOCTOR SECTION

  • is on a sodium-restricted diet
  • has kidney disease

Ask a doctor before using any laxative if the child has:

OTC - ASK DOCTOR SECTION

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

Stop use and consult a doctor if the child has

OTC - STOP USE SECTION

  • rectal bleeding
  • no bowel movement ater 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 
 children 5 to 11 years One bottle or as directed by a doctor
 children 2 to under 5 years one-half bottle (see below)
 children under 2 years DO NOT USE

One-half bottle prepararation:Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow DIRECTIONS on back of carton.

 

Other Information

OTHER SAFETY INFORMATION

Sodium Content 2.2 g

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium EDTA, purified water

Questions?

OTC - QUESTIONS SECTION

C.B. Fleet Co., Inc.

4615 Murray Place

Lynchburg, VA 24502

U.S.A.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0132-0552-202021-04-26C16284748780-19d75b9d0-0715-f424-e053-dadaa90a57ceFleet Enema, Child, Hong Kong 0132-0552-20
0132-0552-202020-01-31C16284748780-19d75b9d0-0715-f424-e053-dadaa90a57ceFleet Enema, Child, Hong Kong 0132-0552-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0552FLEET FOR CHILDREN (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]2Unmatched20210427_dfccb50b-b09c-44a8-9db5-4d2b329a71c9.zip

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
0132-05520132-0552-20

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
d2f24c95-54bd-4f62-ba67-63a9bf5d12f1dfccb50b-b09c-44a8-9db5-4d2b329a71c92026-03-05WarningsExact identifier
spl set id: dfccb50b-b09c-44a8-9db5-4d2b329a71c9

Reported adverse events (FAERS/openFDA)#

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