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Pedia-Lax by C.B. Fleet Company, Inc.

Medically reviewed on August 18, 2017

Dosage form: enema
Ingredients: SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3.5g in 66mL, sodium phosphate, monobasic 9.5g in 66mL
Labeler: C.B. Fleet Company, Inc.
NDC Code: 0132-0202

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.

Drug Facts

Active Ingredient (in each 59-mL delivered dose)

Monobasic Sodium Phosphate 9.5 g, Saline Laxative

Dibasic Sodium Phosphate 3.5 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:

  • for more than 3 days
  • if your child has 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 the 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 or 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 unless directed by a doctor. See Warnings.

Do not use if child is taking another sodium phosphates product.

children 5 to 11 years1 bottle per day or as directed by a doctor
children 2 to under 5 yearsone-half bottle per day (see below)
children under 2 yearsDO NOT USE

One-half bottle prepararation: Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow "How to use this enema" directions.

Other Information
  • each 59-mL delivered dose contains: sodium 2.2 g
  • additional liquids by mouth are recommended while taking this product
  • this product generally produces a bowel movement in 1-5 minutes
  • BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE
  • for complete professional use warnings and precautions, consult the Reference Safety Information on our website

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

1-866-255-6960

www.pedia-lax.com

PEDIA-LAX 
sodium phosphate, dibasic and sodium phosphate, monobasic enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0202
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE3.5 g  in 66 mL
sodium phosphate, monobasic (SODIUM CATION and PHOSPHATE ION) sodium phosphate, monobasic9.5 g  in 66 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
WATER 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:0132-0202-2066 mL in 1 BOTTLE, WITH APPLICATOR
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)
Establishment
NameAddressID/FEIOperations
C.B. Fleet Company, Inc.003119054manufacture(0132-0202)

 
C.B. Fleet Company, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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