NDC 0363-0440 Walgreens Children Glycerin Laxative

NDC Product Code 0363-0440

NDC CODE: 0363-0440

Proprietary Name: Walgreens Children Glycerin Laxative 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.

NDC Code Structure

NDC 0363-0440-12

Package Description: 62.5 g in 1 JAR

NDC 0363-0440-25

Package Description: 62.5 g in 1 JAR

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Walgreens Children Glycerin Laxative with NDC 0363-0440 is a product labeled by Walgreens. The product's dosage form is and is administered via form.

Walgreens Children Glycerin Laxative 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.


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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

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.

Labeler Name: Walgreens
Labeler Code: 0363
Start Marketing Date: 10-06-2014 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: 12-31-2018 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Walgreens Children Glycerin Laxative Product Label Images

Walgreens Children Glycerin Laxative 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 suppository)Glycerin, USP 1.2 grams

Uses

-relieves occasional constipation (irregularity)-generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only

Do Not Use

Do not use laxative products for longer than 1 week unless directed by a doctor

Ask A Doctor Before Use If Your Child Have

Ask a doctor before use if your child have- stomach pain - nausea - vomiting - a sudden change in bowel habits that lasts over 2 weeks

When Using This Product

When using this product your child may have rectal discomfort or a burning sensation

Stop Use And Ask A Doctor If

Stop use and ask a doctor if your child has rectal bleeding or fail to have a bowel movement after use of a laxative.These could be signs of a serious condition.

Keep Out Of Reach Of Children.

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

Directions

Children 2 to under 6 years...........carefully insert 1 suppository well into the rectum and retain for 15 minutes; it need not melt to produce laxative action.  Do not exceed 1 suppository daily or as directed by a doctor.children under 2 years..................ask a doctor

Other Information

-keep tightly closed -avoid excessive heat

Inactive Ingredients

Purified water, sodium hydroxide, stearic acid

Purpose

Laxative

* Please review the disclaimer below.