PEDIA-LAX- 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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Pedia-Lax Enema Saline Laxative 0132-0202

PEDIA-LAX sodium phosphates Saline Enema
C.B. Fleet Company, Inc.

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Drug Facts

Active Ingredients

(in each 59-mL delivered dose)

Monobasic Sodium Phosphate 9.5 g................

Dibasic Sodium Phosphate 3.5 g........................

Purpose

Saline laxative

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:

  • for more than 3 days
  • if your child has a kidney disease
  • if your child has heart problems
  • if your child is dehydrated

Ask a doctor before using this product if the child

  • is on a sodium-restricted diet

Ask a doctor before using any laxative if your 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 ask a doctor if your child has

  • rectal bleeding
  • no bowel movement or no liquid comes out of the child’s rectum after 30 minutes
  • symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal]

These symptoms may indicate a serious condition.

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

 Age Dose
 children 5 to 11 years 1 bottle per day or as directed by doctor
children 2 to under 5 years one-half bottle per day (see below)
 children under 2 years DO NOT USE

One-half bottle preparation:
Unscrew cap and remove 2 tablesppons of liquid with a measuring spoon. Replace cap and follow “How to use this enema” directions.

Other information

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

1-866-255-6960

www.pedia-lax.com

Fleet®  Enemas are LATEX-FREE

PRINCIPAL DISPLAY PANEL

Pedia-Lax
Sodium Phosphates  
Saline Enema
2.25 fl oz (66 mL)

PRINCIPAL DISPLAY PANEL
Pedia-Lax
Sodium Phosphates  
Saline Enema
2.25 fl oz (66 mL)

PEDIA-LAX 
sodium phosphate, dibasic and sodium phosphate, monobasic enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0202
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, HEPTAHYDRATE3.5 g  in 66 mL
sodium phosphate, monobasic (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) sodium phosphate, monobasic9.5 g  in 66 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:0132-0202-2066 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/10/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/10/2002
Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 6/2023
Document Id: b5e01333-93ab-4725-b9b5-bb17c5968729
Set id: f001a37d-8ed4-428b-af12-d6a83c22c127
Version: 10
Effective Time: 20230626
 
C.B. Fleet Company, Inc.