NDC 0113-7425 Basic Care Allergy
Fexofenadine Hcl Tablet, Film Coated Oral

Product Information

What is NDC 0113-7425?

The NDC code 0113-7425 is assigned by the FDA to the product Basic Care Allergy which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Allergy is fexofenadine hcl. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0113-7425-53 12 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack, 0113-7425-78 1 bottle in 1 carton / 100 tablet, film coated in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0113-7425
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.
Basic Care Allergy
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.
Fexofenadine Hcl
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 FormTablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
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.
L. Perrigo Company
Labeler Code0113
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.
ANDA076447
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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
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.
04-10-2019
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.
12-31-2023
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

What are the uses for Basic Care Allergy?


Product Characteristics

Color(s)ORANGE (C48331 - PEACH)
ShapeROUND (C48348)
Size(s)8 MM
Imprint(s)93;7252
Score1

Product Packages

NDC Code 0113-7425-53

Package Description: 12 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK

NDC Code 0113-7425-78

Package Description: 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE

Product Details

What are Basic Care Allergy Active Ingredients?

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.

Basic Care Allergy Active Ingredients UNII Codes

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:

Basic Care Allergy Inactive Ingredients UNII Codes

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.

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.

Patient Education

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.

Basic Care Allergy Product Label

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.

Product Label Table of Contents



Active Ingredient (In Each Tablet)



Fexofenadine HCl 60 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • •runny nose
  • •itchy, watery eyes
  • •sneezing
  • •itching 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 Product



  • •do not take more than directed
  • •do not take at the same time as aluminum or magnesium antacids
  • •do 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 (1-800-222-1222).


Directions



adults and children 12 years of age and over

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor


Other Information



  • •do not use if printed blister unit is broken or torn
  • •store between 20°-25°C (68°-77°F)
  • •protect from excessive moisture
  • •this product meets the requirements of USP Dissolution Test 3

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to Allegra® Allergy 12 HR active ingredient

NON-DROWSY

allergy

Fexofenadine Hydrochloride Tablets, 60 mg / Antihistamine

12 HR

actual size

INDOOR/OUTDOOR ALLERGY RELIEF

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

12 TABLETS


* Please review the disclaimer below.