NDC 41167-4232 Childrens Allegra Allergy

Fexofenadine Hydrochloride

NDC Product Code 41167-4232

NDC CODE: 41167-4232

Proprietary Name: Childrens Allegra Allergy 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: Fexofenadine Hydrochloride 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
E;311;AV
Score: 1
Flavor(s):
ORANGE (C73406 - ORANGE CREAM)

NDC Code Structure

NDC 41167-4232-1

Package Description: 2 BLISTER PACK in 1 CARTON > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

NDC 41167-4232-6

Package Description: 4 BLISTER PACK in 1 CARTON > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

NDC Product Information

Childrens Allegra Allergy with NDC 41167-4232 is a a human over the counter drug product labeled by Chattem, Inc.. The generic name of Childrens Allegra Allergy is fexofenadine hydrochloride. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

Labeler Name: Chattem, Inc.

Dosage Form: Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.

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.

Childrens Allegra Allergy 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.

  • FEXOFENADINE HYDROCHLORIDE 30 mg/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.

  • ASPARTAME (UNII: Z0H242BBR1)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Chattem, Inc.
Labeler Code: 41167
FDA Application Number: NDA021909 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: NDA - A product marketed under an approved New Drug Application. 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: 01-02-2014 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: 12-31-2021 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 - NO 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.

Information for Patients

Fexofenadine

Fexofenadine is pronounced as (fex oh fen' a deen)

Why is fexofenadine medication prescribed?
Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching...
[Read More]

* Please review the disclaimer below.

Childrens Allegra Allergy 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 tablet)Fexofenadine HCI 30 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, water eyesitching of the nose or throat

Do Not Use

If you have ever had an allergic reaction to this product or any of its ingredients.

Ask A Doctor Before Use If You Have

  • Kidney disease. Your doctor should determine if you need a different dose. When using this productdo not take more than directeddo not take at the same time as aluminum or magnesium antacidsdo not take with fruit juices (see Directions)

Stop Use And Ask A Doctor If

An allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Place 1 tablet on tongue; tablet disintegrates, with or without wateradults and children 12 years of age and overtake 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hourschildren 6 to under 12 years of agetake 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hourschildren under 6 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor

Other Information

  • Each tablet contains: sodium 5 mgphenylketonurics: contains phenylalanine 5.3 mg per tabletsafety sealed: do not use if carton is opened or if individual blister units are torn or openedstore between 20º and 25ºC (68º and 77ºF)use tablet immediately after opening individual blister

Inactive Ingredients

Aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate

* Please review the disclaimer below.