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Pedia-Lax by C.B. Fleet Company, Inc.

Dosage form: liquid
Ingredients: DOCUSATE SODIUM 50mg in 15mL
Labeler: C.B. Fleet Company, Inc.
NDC Code: 0132-0106

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.

Drug Facts

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

PEDIA-LAX 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
XYLITOL 
XANTHAN GUM 
WATER 
SUCRALOSE 
SORBITOL 
SODIUM CITRATE 
POVIDONE 
METHYLPARABEN 
PROPYLENE GLYCOL 
ANHYDROUS CITRIC ACID 
FD&C RED NO. 3 
POLYETHYLENE GLYCOL 4500 
PROPYLPARABEN 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0132-0106-24118 mL in 1 CARTON
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/FEIOperations
C.B. Fleet Company, Inc.003119054manufacture(0132-0106)

Revised: 09/2017
 
C.B. Fleet Company, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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