FLEET FOR CHILDREN

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2021-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:04

Label at a glance#

ProductFLEET FOR CHILDREN
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   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 preparation: 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 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 
 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 preparation: 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

Fleet
ready-to-use
enema for children.

PRINCIPAL DISPLAY PANEL Fleet ready-to-use enema for children.PRINCIPAL DISPLAY PANEL Fleet ready-to-use enema for children.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSN1
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD1
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY1
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0565-40FLEET FOR CHILDREN66 mL in 1 BOTTLE, WITH APPLICATORENEMA661

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0565FLEET FOR CHILDREN (SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]11 package rows20210429_ea431796-2870-4932-a4e3-fb63f962a5d4.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-05650132-0565-40

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
5b68e907-94ad-450b-a11c-01f2f5d51d0eea431796-2870-4932-a4e3-fb63f962a5d42021-04-29WarningsExact identifier
spl id: 5b68e907-94ad-450b-a11c-01f2f5d51d0e
spl set id: ea431796-2870-4932-a4e3-fb63f962a5d4

Reported adverse events (FAERS/openFDA)#

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