NDC 0132-0190 Pedia-lax

Glycerin

NDC Product Code 0132-0190

NDC CODE: 0132-0190

Proprietary Name: Pedia-lax 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.

Non-Proprietary Name: Glycerin 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

  • 0132 - C.b. Fleet Company, Inc.

NDC 0132-0190-12

Package Description: 4 LIQUID in 1 CARTON

NDC Product Information

Pedia-lax with NDC 0132-0190 is a 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.

Labeler Name: C.b. Fleet Company, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Pedia-lax Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GLYCERIN 2.8 g/1

Inactive Ingredient(s)

About the 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.

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

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.
  • 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.

Labeler Name: C.b. Fleet Company, Inc.
Labeler Code: 0132
FDA Application Number: part334 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 03-01-2008 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pedia-lax Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each 2.7 Ml Average Delivered Dose)

Glycerin 2.8 g, Hyperosmotic Laxative

Uses

  • For relief of occasional constipationThis product generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use onlyMay cause rectal discomfort or a burning sensation.

Ask A Doctor Before Using Any Laxative If The Child Has

  • Abdominal pain, nausea or vomitinga sudden change in bowel habits lasting more than 2 weeksalready used a laxative for more than 1 weekif 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 bleedingno bowel movement within 1 hour of using this productThese 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 years1 suppository, or as directed by a doctor children under 2 yearsconsult 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

* Please review the disclaimer below.