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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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.


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

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 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

BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE.

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

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

Fleet Enema Extra Carton

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
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; Type 0: Not a Combination Product 06/25/2004
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: 8/2017
Document Id: b574e93a-5c0b-4eaa-b8ce-2e5ffc539afe
Set id: db7520d8-9364-4d7a-ba81-79a2fc2fa40e
Version: 9
Effective Time: 20170822
 
C.B. Fleet Company, Inc.