FDA.reportPublic FDA data

Pedia-Lax

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:40

Label at a glance#

ProductPedia-Lax
Active ingredientGLYCERIN
Label structure9 sections

Indications and uses

for relief of occasional constipation this product generally produces bowel movement in 1/4 to 1 hour

Dosage and administration

Single Daily Dosage (per 24 hours) children 2 to under 6 years : one suppository per day or as directed by a doctor children under 2 years : consult a doctor Administering the laxative: CAUTION: REMOVE ORANGE PROTECTIVE SHIELD BEFORE INSERTING. Hold unit upright, grasping bulb of unit with fingers. Grasp orange protective shield with other hand, pull gently to remove. With steady pressure, gently insert tip into r...

Label contents#

Full prescribing information#

Active ingredient (in each 2.7 mL average delivered dose)

OTC - ACTIVE INGREDIENT SECTION

Glycerin 2.8 g

Purpose

OTC - PURPOSE SECTION

Hyperosmotic laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation
  • this product generally produces bowel movement in 1/4 to 1 hour

Warnings

WARNINGS SECTION

For rectal use only

May cause rectal discomfort or a burning sensation.

Ask a doctor before using any laxative if the child has

OTC - ASK DOCTOR SECTION

  • 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
  • if constipation continues after one week of use, contact your child's doctor

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

OTC - STOP USE SECTION

  • rectal bleeding
  • no bowel movement within 1 hour of using this product

These symptoms may indicate a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Single Daily Dosage (per 24 hours)

children 2 to under 6 years: one suppository per day or as directed by a doctor

children under 2 years: consult a doctor

Administering the laxative:

CAUTION: REMOVE ORANGE PROTECTIVE SHIELD BEFORE INSERTING. Hold unit upright, grasping bulb of unit with fingers. Grasp orange protective shield with other hand, pull gently to remove. With steady pressure, gently insert tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Discontinue use if resistance is encountered. Forcing the tip can result in injury. Insertion may be easier if child receiving suppository bears down as if having a bowel movement. This helps relax the muscles around the anus. Squeeze the bulb until nearly all liquid is expelled. While continuing to squeeze the bulb, remove tip from rectum and discard unit. It is not necessary to empty unit completely. The unit contains more than the amount of liquid needed for effective use. A small amount of liquid will remain in the unit after squeezing.

Left-side position: Place child on left side with knees bent and arms resting comfortably.

Knee-chest position: Have child kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.

Other information

OTHER SAFETY INFORMATION

carton sealed for safety. If seal with Fleet emblem on bottom flap or top flap is broken or missing, do not use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

edetate disodium, purified water

PRINCIPAL DISPLAY PANEL 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Baby Care

Pedia-Lax ®

Liquid glycerin suppositories

rectal laxative

6 applicators (4 ml each)

PRINCIPAL DISPLAY PANEL Baby Care Pedia-Lax ® Liquid glycerin suppositories rectal laxative 6 applicators (4 ml each)PRINCIPAL DISPLAY PANEL Baby Care Pedia-Lax ® Liquid glycerin suppositories rectal laxative 6 applicators (4 ml each)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
895966glycerin 2.8 GM in 2.7 mL EnemaPSN2
1190433Pedia-Lax Liquid Glycerin Suppositories 2.8 GM in 2.7 mL EnemaPSN2
1190433glycerin 1037 MG/ML Enema [Pedia-Lax Liquid Glycerin Suppositories]SBD2
895966glycerin 1037 MG/ML EnemaSCD2
895966glycerin 2.8 GM per 2.7 ML EnemaSY2
1190433Pedia-Lax Liquid Glycerin Suppositories 2.8 GM per 2.7 ML EnemaSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0195-12Pedia-Lax4 mL in 1 APPLICATORLIQUID42
0132-0195-12Pedia-Lax6 in 1 CARTONLIQUID62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0195PEDIA-LAX (GLYCERIN) LIQUID [C.B. FLEET COMPANY, INC.]2Current NDC, Legacy NDC, 2 package rows20241211_ae367381-7146-4307-823d-2bb44c1d4200.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-01950132-0195-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT

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-LaxGLYCERINC.B. Fleet Company, Inc.ae367381-7146-4307-823d-2bb44c1d42002024-10-25WarningsExact identifier
ndc (package): 0132-0195-12
ndc (product): 0132-0195
ndc11 (package): 00132019512
spl id: e622c043-75e3-4c55-95dd-e243325b84dc
spl set id: ae367381-7146-4307-823d-2bb44c1d4200

Reported adverse events (FAERS/openFDA)#

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