FLEET- enema enema 
C.B. Fleet Company, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient (in each 118-mL delivered dose)

Monobasic Sodium Phosphate 19 g, Saline Laxative
Dibasic Sodium Phosphate 7 g, Saline Laxative

Use

For relief of occasional constipation

Warnings

For rectal use only.

Dosage warning:

Using more than one enema in 24 hours can be harmful. Do not use without asking a doctor:

Ask a doctor before using this product if you


Ask a doctor before using any laxative if you have

Stop use and ask a doctor if you have

These symptoms may indicate a serious condition

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children

Keep out of reach of children to prevent accidental ingestion.

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

Directions

Single Daily Dosage (per 24 hours).

Do not use more unless directed by a doctor. See Warnings.

Do not use if taking another sodium phosphates product.

 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

Other Information

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

1-866-255-6960 or www.fleetlabs.com

Fleet Enema Six Pack Carton

FLEET 
enema enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0119
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC19 g  in 133 mL
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC7 g  in 133 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0119-46133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/26/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/26/2011
Labeler - C.B. Fleet Company, Inc. (003119054)
Establishment
NameAddressID/FEIBusiness Operations
C.B. Fleet Company, Inc.003119054manufacture(0132-0119)

Revised: 8/2017
Document Id: 5d796181-8d4f-4fb3-b0d2-89352cd9e282
Set id: a2155d4e-ab12-4bce-80d1-47e31195a060
Version: 4
Effective Time: 20170829
 
C.B. Fleet Company, Inc.