PEDIA-LAX- docusate sodium liquid 
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.

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Drug Facts

Active Ingredients

(in each tablespoon)

Docusate sodium 50 mg, Stool softener

Uses

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

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

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

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

Pedia-Lax Liquid Stool Softener Carton

PEDIA-LAX 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScore    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0106-24118 mL in 1 CARTON; Type 0: Not a Combination Product03/01/2008
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)
Establishment
NameAddressID/FEIBusiness Operations
C.B. Fleet Company, Inc.003119054manufacture(0132-0106)

Revised: 9/2017
Document Id: e8816dce-8c24-4e27-9a41-b64eecb0497a
Set id: d96986dd-eab8-4025-9987-77deb208972e
Version: 6
Effective Time: 20170929
 
C.B. Fleet Company, Inc.