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NDC 00132-0190-12 Pedia-Lax 2.8 g/1 Details

Pedia-Lax 2.8 g/1

Pedia-Lax is a RECTAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by C.B. Fleet Company, Inc.. The primary component is GLYCERIN.

Product Information

NDC	00132-0190
Product ID	0132-0190_3f2cb644-2271-42c1-a64b-6351c07e698e
Associated GPIs	46600010005264
GCN Sequence Number	065949
GCN Sequence Number Description	glycerin SOL/PF APP 2.8G/2.7ML RECTAL
HIC3	Q3S
HIC3 Description	LAXATIVES, LOCAL/RECTAL
GCN	28087
HICL Sequence Number	001312
HICL Sequence Number Description	GLYCERIN
Brand/Generic	Brand
Proprietary Name	Pedia-Lax
Proprietary Name Suffix	n/a
Non-Proprietary Name	Glycerin
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	RECTAL
Active Ingredient Strength	2.8
Active Ingredient Units	g/1
Substance Name	GLYCERIN
Labeler Name	C.B. Fleet Company, Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00132-0190-12 (00132019012)

Pricing Information
NDC Package Code	0132-0190-12
Billing NDC	00132019012
Package	4 LIQUID in 1 CARTON (0132-0190-12)
Marketing Start Date	2008-03-01
NDC Exclude Flag	N
Price Per Unit	0.19504
Pricing Unit	ML
Effective Date	2022-08-17
NDC Description	FLEET PEDIA-LAX SUPPOSITORIES
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	2, 5
Classification for Rate Setting	B
As of Date	2022-09-28

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 4e15f6ca-a40c-485f-be3f-07c2ed7cb498 Details

Active Ingredient (in each 2.7 mL average delivered dose)

Glycerin 2.8 g, Hyperosmotic Laxative

Uses

For relief of occasional constipation
This product generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only

May cause rectal discomfort or a burning sensation.

Ask a doctor before using any laxative if the child has

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

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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Single daily dosage (per 24 hours)

children 2 to under 6 years	1 suppository, or as directed by a doctor
children under 2 years	consult a doctor

Other 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

edetate disodium, purified water

Questions?

1-866-255-6960 or www.pedia-lax.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEDIA-LAX

glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0190
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2.8 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0132-0190-12	4 in 1 CARTON; Type 0: Not a Combination Product	03/01/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/01/2008

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

Name	Address	ID/FEI	Business Operations
Establishment
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0190)

Revised: 10/2017

Document Id: 3f2cb644-2271-42c1-a64b-6351c07e698e

Set id: 4e15f6ca-a40c-485f-be3f-07c2ed7cb498

Version: 4

Effective Time: 20171026