PEDIA-LAX- glycerin liquid

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 2.7 mL average delivered dose)

Glycerin 2.8 g, Hyperosmotic Laxative

Uses

• For relief of occasional constipation
• This product generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only

May cause rectal discomfort or a burning sensation.

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
• if constipation continues after one week of use, contact your child's doctor

Stop using this product and consult a doctor if the child has

• rectal bleeding
• no bowel movement within 1 hour of using this product

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 (per 24 hours)

• children 2 to under 6 years: 1 suppository, or as directed by a doctor
• children under 2 years: consult a doctor

Other Information

• carton sealed for safety. If seal with Fleet emblem on bottom flap or top flap is broken or missing, do not use.

Inactive Ingredients

edetate disodium, purified water

Questions?

1-866-255-6960 or www.pedia-lax.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEDIA-LAX 
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0190
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2.8 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0190-12	4 in 1 CARTON; Type 0: Not a Combination Product	03/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/01/2008

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

Establishment
Name	Address	ID/FEI	Business Operations
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0190)