Your browser does not support JavaScript! FLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]
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RxNorm Names

FLEET (sodium phosphate, dibasic and sodium phosphate, monobasic) enema
[C.B. Fleet Company, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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

  • is on a sodium-restricted diet
  • has kidney disease

Ask a doctor before using any laxative if the child has
  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week 

Stop use and consult a doctor if the child has

  • rectal bleeding
  • no bowel movement within 30 minutes of enema use
  • symptoms of dehydration (feeling thirsty, dizziness, vomiting or urinating less often than normal)
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

  • each 197-mL delivered dose contains: sodium 4.4 g
  • additional liquids by mouth are recommended while taking this product
  • this product generally produces a bowel movement in 1-5 minutes
  • carton sealed for safety. If seal with Fleet emblem on top or bottom flap is broken or missing, do not use
  • for complete professional use warnings and precautions, consult Physicians' Desk Reference

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0201
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE7 g  in 230 mL
sodium phosphate, monobasic (SODIUM CATION and PHOSPHATE ION) sodium phosphate, monobasic19 g  in 230 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
WATER 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:0132-0201-10230 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/25/2004
Labeler - C.B. Fleet Company, Inc. (003119054)
Establishment
NameAddressID/FEIBusiness Operations
C.B. Fleet Company, Inc.003119054manufacture(0132-0201)

Revised: 02/2013
Document Id: e09a2151-442e-4d18-a14c-424eb224e7e0
Set id: db7520d8-9364-4d7a-ba81-79a2fc2fa40e
Version: 8
Effective Time: 20130213
 
C.B. Fleet Company, Inc.

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