FLEET- sodium phosphate, dibasic, heptahydrate 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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Drug Facts

Active Ingredient (in each 197-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.


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

Ask a doctor before using this product if the child


Ask a doctor before using any laxative if the child has

Stop use and consult a doctor if the child has

These symptoms may indicate a serious condition.

Keep out of reach of children

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

Directions

Single Daily Dosage


Do not use more unless directed by a doctor. See Warnings. Do not use if child is taking another sodium phosphates product.

children 5 to 11 years
1 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 prepararation:
Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow directions.

Other Information

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

1-866-255-6960 or www.pedia-lax.com

image of label

FLEET 
sodium phosphate, dibasic and sodium phosphate, monobasic enema
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0201
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 7 g  in 230 mL
sodium phosphate, monobasic (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) sodium phosphate, monobasic 19 g  in 230 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0132-0201-10 230 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 06/25/2004
Labeler - C.B. Fleet Company, Inc. (003119054)
Establishment
Name Address ID/FEI Business Operations
C.B. Fleet Company, Inc. 003119054 manufacture(0132-0201)

Revised: 2/2013
Document Id: e09a2151-442e-4d18-a14c-424eb224e7e0
Set id: db7520d8-9364-4d7a-ba81-79a2fc2fa40e
Version: 8
Effective Time: 20130213
 
C.B. Fleet Company, Inc.