PEDIA-LAX- docusate sodium liquid

Pedia-Lax by

Drug Labeling and Warnings

Pedia-Lax by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

PediaLax

Docusate sodium

Liquid Stool Softener

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

PEDIA-LAX 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white (Colorless)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0113-24	118 mL in 1 CARTON; Type 0: Not a Combination Product	02/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	02/28/2023

Labeler - C.B. Fleet Company, Inc. (003119054)