FDA.reportPublic FDA data

Pedia-Lax

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:22:12

Label at a glance#

ProductPedia-Lax
Active ingredientDOCUSATE SODIUM
Label structure11 sections

Indications and uses

for prevention of dry, hard stools for relief of occasional constipation this product usually produces a bowel movement in 12 to 72 hours

Dosage and administration

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 pan...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each 15 mL)

Docusate Sodium 50 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

for prevention of dry, hard stools

for relief of occasional constipation

this product usually produces a bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

citric acid, edetate disodium, flavor, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, sodium citrate, sorbitol, sucralose, water, xanthan gum, xylitol

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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•Lax Docusate sodium Liquid Stool Softener 4 fl oz (118 mL)Pedia•Lax Docusate sodium Liquid Stool Softener 4 fl oz (118 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1088245docustate sodium 50 MG in 15 mL Oral SolutionPSN1
1088249Pedia-Lax Stool Softener 50 MG in 15 mL Oral SolutionPSN1
1088249docusate sodium 3.33 MG/ML Oral Solution [Pedia-Lax Liquid]SBD1
1088245docusate sodium 3.33 MG/ML Oral SolutionSCD1
1088245docusate sodium 100 MG per 30 ML Oral SolutionSY1
1088245docusate sodium 50 MG per 15 ML Oral SolutionSY1
1088245DOSS Sodium 3.33 MG/ML Oral SolutionSY1
1088249DOSS Sodium 3.33 MG/ML Oral Solution [Pedia-Lax Liquid]SY1
1088249Pedia-Lax Liquid 3.33 MG/ML Oral SolutionSY1
1088249Pedia-Lax Stool Softener 50 MG per 15 ML Oral SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0113-24Pedia-Lax118 mL in 1 CARTONLIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0113PEDIA-LAX (DOCUSATE SODIUM) LIQUID [C.B. FLEET COMPANY, INC.]1Current NDC, 1 package rows20240929_0e908bea-ebab-44e7-919c-90002e6f5d42.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-01130132-0113-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
XYLITOLVCQ006KQ1EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pedia-LaxDOCUSATE SODIUMC.B. Fleet Company, Inc.0e908bea-ebab-44e7-919c-90002e6f5d422024-10-01WarningsExact identifier
ndc (package): 0132-0113-24
ndc (product): 0132-0113
ndc11 (package): 00132011324
spl id: 6c2dec84-5645-49f0-a3c2-882f4e28d67e
spl set id: 0e908bea-ebab-44e7-919c-90002e6f5d42

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.