Pedia-lax Liquid
FDA Label NDC 0132-0113

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

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.

Active Ingredients

(in each 15 mL)

Docusate Sodium 50 mg

Purpose

Stool softener

Uses

for prevention of dry, hard stools

for relief of occasional constipation

this product usually produces a bowel movement in 12 to 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

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

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 (1-800-222-1222) right away.

Directions

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).

Other Information

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

Inactive Ingredients

citric acid, edetate disodium, 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

Principal Display Panel

Pedia-Lax
Docusate sodium
Liquid Stool Softener
4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL

Pedia•Lax

Docusate sodium

Liquid Stool Softener

4 fl oz (118 mL)

Pedia•laxdocusate Sodiumliquid Stool Softener4 Fl Oz (118 mL) (Pedia Lax Docusate Stool Softener 0132 0113 01)

Pedia•laxdocusate Sodiumliquid Stool Softener4 Fl Oz (118 mL) (Pedia Lax Docusate Stool Softener 0132 0113 01)

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