PEDIA-LAX- sodium phosphate, dibasic and sodium phosphate, monobasic enema

Pedia-Lax by

Drug Labeling and Warnings

Pedia-Lax by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 years: 1 bottle per day or as directed by a doctor
• children 2 to under 5 years: one-half bottle per day (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 "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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEDIA-LAX 
sodium phosphate, dibasic and sodium phosphate, monobasic enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0202
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	3.5 g  in 66 mL
sodium phosphate, monobasic (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)	sodium phosphate, monobasic	9.5 g  in 66 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: 0132-0202-20	66 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/10/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/10/2002

Labeler - C.B. Fleet Company, Inc. (003119054)

Establishment
Name	Address	ID/FEI	Business Operations
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0202)