FDA.reportPublic FDA data

Pedia-Lax

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:53:03

Label at a glance#

ProductPedia-Lax
Active ingredientGLYCERIN
Label structure9 sections

Indications and uses

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

Dosage and administration

Single Daily Dosage (per 24 hours) children 2 to under 6 years 1 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 ...

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 usually 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 1 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 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

Pedia-Lax®
Glycerin Laxative
Liquid Glycerin Suppositories
6 APPLICATORS
(4 mL EACH)

Pedia-Lax Glycerin Laxative Liquid Glycerin Suppositories 6 APPLICATORS (4 mL EACH)Pedia-Lax Glycerin Laxative Liquid Glycerin Suppositories 6 APPLICATORS (4 mL EACH)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
895966glycerin 2.8 GM in 2.7 mL EnemaPSN11
1190433Pedia-Lax Liquid Glycerin Suppositories 2.8 GM in 2.7 mL EnemaPSN11
1190433glycerin 1037 MG/ML Enema [Pedia-Lax Liquid Glycerin Suppositories]SBD11
895966glycerin 1037 MG/ML EnemaSCD11
895966glycerin 2.8 GM per 2.7 ML EnemaSY11
1190433Pedia-Lax Liquid Glycerin Suppositories 2.8 GM per 2.7 ML EnemaSY11

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
0132-0190-12Pedia-Lax4 mL in 1 APPLICATORLIQUID411
0132-0190-12Pedia-Lax6 in 1 CARTONLIQUID611

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0190PEDIA-LAX (GLYCERIN) LIQUID [C.B. FLEET COMPANY, INC.]11Current NDC, Legacy NDC, 2 package rows20250119_4e15f6ca-a40c-485f-be3f-07c2ed7cb498.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0132-0190-12ML - Milliliter0132-01900fb99c8a-0c19-47fe-843f-9116b56a419b12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GlycerinACTIVE INGREDIENTPDC6A3C0OX3
GlycerinACTIVE MOIETYPDC6A3C0OX3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
WATERINACTIVE INGREDIENT059QF0KO0R3

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
0132-01900132-0190-12

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
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RECTAL97 mgExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii+dosage form
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii+dosage form
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RECTAL97 mgExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii+dosage form
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii+dosage form
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii+dosage form
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii+route
12 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii+dosage form
12 equally ranked IID candidates

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.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
ndc (package): 0132-0190-12
ndc (product): 0132-0190
ndc11 (package): 00132019012
spl id: 530334c7-fa4f-462f-8816-5ad794056ef4
spl set id: 4e15f6ca-a40c-485f-be3f-07c2ed7cb498

Reported adverse events (FAERS/openFDA)#

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