PEDIA-LAX- magnesium hydroxide tablet, chewable

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

Magnesium hydroxide 400 mg

Purpose

Saline laxative

Uses

• for relief of occasional constipation
• this product usually produces bowel movement in 1/2 to 6 hours

Warnings

Ask a doctor before using any laxative if child has

• kidney disease
• a magnesium-restricted diet
• abdominal pain, nausea or vomiting
• a sudden change in bowel habits lasting more than 2 weeks
• constipation continues after 1 week of use, contact your child's doctor
• already used a laxative for more than 1 week

Stop use and consult a doctor if your child has

• rectal bleeding
• no bowel movement within 6 hours of using this product

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

Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Drink a full glass (8 ounces) of liquid with each dose.

Age	Starting dose	Starting Dose Maxiumm dose per day (24 hours)
children 6 to under 12 years	3-6 tablets	6 tablets
children 2 to under 6 years	1-3 tablets	3 tablets
children under 2 years	ask a doctor

Other information

• each tablet contains: 170 mg of magnesium
• CHILD RESISTANT CAP
• The top of the bottle sealed for safety.Do not use if foil impreinted "SEALED for YOUR PROTECTION" is broken of missing.
• Gluten Free and Sugar Free

Inactive ingredients

colloidal silicon dioxide, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, mannitol, sorbitol, stearic acid, sucralose

Questions?

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

PRINCIPAL DISPLAY PANEL

Pedia-Lax Chewable Tablets

Saline Laxative

30 chewable tablets

INGREDIENTS AND APPEARANCE

PEDIA-LAX 
magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0655
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor	WATERMELON	Imprint Code	Pedia;Lax
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0655-01	1 in 1 CARTON	03/01/2008
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

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)