NDC 0132-0195 Pedia-lax
Glycerin Liquid Rectal

Product Information

Product Code0132-0195
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Pedia-lax
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Glycerin
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Rectal - Administration to the rectum.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
C.b. Fleet Company, Inc.
Labeler Code0132
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part334
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
02-01-2019
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 0132-0195-12

Package Description: 6 APPLICATOR in 1 CARTON > 4 mL in 1 APPLICATOR

Product Details

Pedia-lax is a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Pedia-lax is glycerin. The product's dosage form is liquid and is administered via rectal form.


What are Pedia-lax Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Pedia-lax Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient (In Each 2.7 Ml Average Delivered Dose)



Glycerin 2.8 g


Purpose



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 (1-800-222-1222) right away.


Directions



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



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



Baby Care

Pedia-Lax ®

Liquid glycerin suppositories

rectal laxative

6 applicators (4 ml each)


* Please review the disclaimer below.