Active Ingredients
(in each 15 mL)
Docusate Sodium 50 mg
The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Pedia-lax (NDC 0132-0113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor before using, stop using this product and consult a doctor if your child has, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each 15 mL)
Docusate Sodium 50 mg
Stool softener
for prevention of dry, hard stools
for relief of occasional constipation
this product usually produces a bowel movement in 12 to 72 hours
Drug Interaction Precaution: Do not give this product to your child if your child is presently taking mineral oil, unless directed by a doctor.
any laxative if your child has
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, contact your child's doctor
rectal bleeding
no bowel movement within 72 hours of using this product
These symptoms may be signs of a serious condition.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
do not give more than 45 mL in any 24 hour period
use only with enclosed dosing cup
find right dose on chart below
mL = milliliter
Age Dose
Children 2 to under 12
years
15 mL to 45 mL; do not take more than 45 mL in 24
hours
Children under 2 years ask a doctor
Doses can be diluted in a suitable beverage to prevent throat irritation and to help mask the naturally tart flavor of the active ingredient (see side panel for info).
each 15 mL contains: sodium 13 mg 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
citric acid, edetate disodium, flavor, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, sodium citrate, sorbitol, sucralose, water, xanthan gum, xylitol
1-866-255-6960 or www.pedia-lax.com
* Please review the disclaimer below.