Fleet

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2021-04-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:40:02

Key Label Information#

Active Ingredients And Purpose

Active Ingredient (in each 118-mL delivered dose)

Monobasic Sodium Phosphate 19 g Laxative / Bowel Cleanser Dibasic Sodium Phosphate 7 g Laxative / Bowel Cleanser

Uses

Use

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

Warnings

Warnings

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

Ask a doctor before using this product if you

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

Ask a doctor before using any laxative if you:

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

Directions And Dosage

Directions

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 Label Information

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

C.B. Fleet Co., Inc. Lynchburg, VA 24502 U.S.A.

Principal Display Panel

Label Images#

fleet-enema-adult-latin-america-0132-0528-40-01
fleet-enema-adult-latin-america-0132-0528-40-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSN4
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD4
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY4
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0132-0528-402021-04-27C16284748780-19d75b9cf-d5f8-f424-e053-dadaa90a57ceFleet Enema, Adult, Latin America 0132-0528-40
0132-0528-402020-01-31C16284748780-19d75b9cf-d5f8-f424-e053-dadaa90a57ceFleet Enema, Adult, Latin America 0132-0528-40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0528-40Fleet133 mL in 1 BOTTLE, WITH APPLICATORENEMA1334

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0528FLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]41 package rows20210428_fecd8564-ef63-4367-9797-fa0a0c33cf85.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEACTIVE INGREDIENT70WT22SF4B3
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SW3
SODIUM CATIONACTIVE MOIETYLYR4M0NH373
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W73
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-05280132-0528-40

Ingredients#

Complete SPL Sections#

Active Ingredient (in each 118-mL delivered dose)

OTC - ACTIVE INGREDIENT SECTION

Monobasic Sodium Phosphate 19 g Laxative / Bowel Cleanser Dibasic Sodium Phosphate 7 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 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

Source Document#

Source XML ยท Source PDF