PEDIA-LAX- magnesium hydroxide tablet, chewable 
C.B. Fleet Company, Inc.

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.

----------

Pedia-Lax Chewable Tablets

Drug Facts

Active Ingredient

Magnesium hydroxide 400 mg

Purpose

Saline laxative

Uses

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.

AgeStarting doseStarting Dose Maxiumm dose per day (24 hours)
children 6 to under 12 years3-6 tablets6 tablets
children 2 to under 6 years 1-3 tablets 3 tablets 
children under 2 yearsask a doctor

Other information

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

Pedia-Lax Chewable Tablets 30 ct carton

PEDIA-LAX 
magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0655
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScore2 pieces
ShapeROUNDSize14mm
FlavorWATERMELONImprint Code Pedia;Lax
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0655-011 in 1 CARTON03/01/2008
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/01/2008
Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 12/2017
Document Id: c8cd2615-8787-45ad-b98e-d1c2b8d23a5a
Set id: 975f24d8-218c-40f4-84a5-558acf34329d
Version: 5
Effective Time: 20171230
 
C.B. Fleet Company, Inc.