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 Ingredient

(in each tablespoon)

Docusate Sodium 50 mg

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 must be given in a 6-8 oz glass of milk or juice, to prevent throat irritation.

Age
Starting Dose
Maximum Dose per Day
children 2 to under 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

image of carton label

PEDIA-LAX 
docusate sodium liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0106
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg  in 118 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
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)

Revised: 2/2013
Document Id: 1224aee7-957c-41cd-a192-4e94a2f8f819
Set id: d96986dd-eab8-4025-9987-77deb208972e
Version: 5
Effective Time: 20130205
 
C.B. Fleet Company, Inc.