PEDIA-LAX- docusate sodium 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 Ingredients

(in each tablespoon)

Docusate sodium 50 mg, Stool softener

Uses

• for the prevention of dry, hard stools
• for relief of occasional constipation
• this product generally produces bowel movement in 12-72 hours

Warnings

Drug interaction precaution: do not give this product to your child if your child is presently taking mineral oil unless directed by a doctor.

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
• if constipation continues after 1 week of use, contac your child's doctor

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

• rectal bleeding
• no bowel movement within 72 horus of using this product

These symptoms may be signs of a serious condition.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Doses can be given in a glass of juice to prevent throat irritation and to help mask the naturally tart flavor of the active ingredient.

Age	Starting Dose	Maximum dose per day (24 hours)
children 2 to 12 years	1 - 3 tablespoons	3 tablespoons
children under 2 years	ask a doctor

Other information

• each tablespoon contains: sodium 13 mg
• CHILD RESISTANT CAP
• The top of the bottle is sealed with foil for your safety. Do not use if foil imprinted "SEALED for YOUR PROTECTION" is broken or missing.
• Gluten Free

Inactive Ingredients

citric acid, edetate disodium, FD and C red 3, flavor, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, sodium citrate, sorbitol, sucralose, water, xanthan gum, xylitol

Questions?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEDIA-LAX 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
XYLITOL (UNII: VCQ006KQ1E)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POVIDONE (UNII: FZ989GH94E)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0106-24	118 mL 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(0132-0106)