Fleet

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2024-03-15
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 21:07:27

Label at a glance#

ProductFleet
Active ingredientSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, sodium phosphate, monobasic
Label structure11 sections

Dosage and administration

Single Daily Dosage (per 24 hours)     Do not use if taking another sodium phosphates product. Do not use more unless directed by a doctor. See Warnings.    Adults and children 12 years and over  1 bottle per day  Children 2 to 11 years  use Fleet ® Pedia-Lax ® Enema  Children under 2 years  DO NOT USE If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of...

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

Saline laxative

Saline laxative

Use

INDICATIONS & USAGE SECTION

for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.

Warnings

WARNINGS SECTION

Using more than one enema in 24 hours can be harmful. For rectal use only.

Do not use

OTC - DO NOT USE SECTION

  • for more than 3 days
  • if you have kidney disease
  • if you have heart problems
  • if you are dehydrated
  • when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask a doctor before using this product if you:

OTC - ASK DOCTOR SECTION

  • are 55 years of age or older
  • are on a sodium-restricted diet
  • have a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Stop use and ask a doctor if you have

OTC - STOP USE SECTION

  • rectal bleeding
  • no bowel movement or no liquid comes out of the rectum after 30 minutes
  • symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal]

These symptoms may indicate a serious condition.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Single Daily Dosage (per 24 hours)  
Do not use if taking another sodium phosphates product.
Do not use
more unless directed by a doctor. See Warnings.  
 Adults and children 12 years and over 1 bottle per day
 Children 2 to 11 years use Fleet® Pedia-Lax® Enema
 Children under 2 years DO NOT USE

If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other Information

OTHER SAFETY INFORMATION

  • each 118 mL delivered dose contains: sodium 4.4 g
  • additional liquids by mouth are recommended while taking this product

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium EDTA, purified water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fleet
Laxative
Saline Enema
1 Bottle 4.5 Fl Oz (133 mL)

PRINCIPAL DISPLAY PANEL Fleet Laxative Saline Enema 1 Bottle 4.5 Fl Oz (133 mL)PRINCIPAL DISPLAY PANEL Fleet Laxative Saline Enema 1 Bottle 4.5 Fl Oz (133 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0201-10ML - Milliliter0132-0201315e3edc-0698-42a4-8fc7-c085107029dd12012-07-24
0132-0201-40ML - Milliliter0132-02017ac30ddb-5abb-4470-bb92-13859a24895b12012-07-24
0132-0201-42ML - Milliliter0132-02010313857d-6432-47ea-b3c9-2b95b642185212017-08-11
0132-0201-45ML - Milliliter0132-0201290f7501-c68f-4ec6-8be3-d18163ea59ef12017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEACTIVE INGREDIENT70WT22SF4B8
sodium phosphate, monobasicACTIVE INGREDIENT3980JIH2SW8
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR8
SODIUM CATIONACTIVE MOIETYLYR4M0NH378
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W78
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K8
WATERINACTIVE INGREDIENT059QF0KO0R8

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
0132-02010132-0201-10

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 50 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRALESIONAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRALESIONAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
48 equally ranked IID candidates

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.c1677d70-203b-493e-88f0-815a66133f1d2025-11-20WarningsExact identifier
ndc (product): 0132-0201
01001e98-f563-4ee1-9f2a-ee47b1e9d714db7520d8-9364-4d7a-ba81-79a2fc2fa40e2024-03-15WarningsExact identifier
spl id: 01001e98-f563-4ee1-9f2a-ee47b1e9d714
spl set id: db7520d8-9364-4d7a-ba81-79a2fc2fa40e

Reported adverse events (FAERS/openFDA)#

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