Your browser does not support JavaScript! PEDIA-LAX (DOCUSATE SODIUM) LIQUID [C.B. FLEET COMPANY, INC.]
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RxNorm Names

PEDIA-LAX (docusate sodium) liquid
[C.B. Fleet Company, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredient

(in each tablespoon)

Docusate Sodium 50 mg

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

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

  • rectal bleeding
  • no bowel movement within 72 hours 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 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


  • 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.

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0132-0106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg  in 118 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 DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
C.B. Fleet Company, Inc.003119054manufacture(0132-0106)

Revised: 2/2013
 
C.B. Fleet Company, Inc.

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