FLEET- sodium phosphate, dibasic and sodium phosphate, monobasic 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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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 then 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 consult a doctor if you have

These symptoms may indicate a serious condition.

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.

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

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.

Other Information

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

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

Fleet Enema Principle Display Panel

Fleet Enema Carton

FLEET 
sodium phosphate, dibasic and sodium phosphate, monobasic enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0201
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE7 g  in 133 mL
sodium phosphate, monobasic (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) sodium phosphate, monobasic19 g  in 133 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0201-40133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
2NDC:0132-0201-42133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
3NDC:0132-0201-45133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/10/1953
Labeler - C.B. Fleet Company, Inc. (003119054)
Establishment
NameAddressID/FEIBusiness Operations
C.B. Fleet Company, Inc.003119054manufacture(0132-0201)

Revised: 6/2017
Document Id: 00c5b580-1fe5-49f0-bbca-25506c75cf6f
Set id: c1677d70-203b-493e-88f0-815a66133f1d
Version: 8
Effective Time: 20170616
 
C.B. Fleet Company, Inc.