NDC 70000-0042 Leader Allergy Relief D
Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Rel...

Product Information

What is NDC 70000-0042?

The NDC code 70000-0042 is assigned by the FDA to the product Leader Allergy Relief D which is a human over the counter drug product labeled by Cardinal Health 110, Llc. Dba Leader. The generic name of Leader Allergy Relief D is cetirizine hydrochloride, pseudoephedrine hydrochloride. The product's dosage form is tablet, film coated, extended release and is administered via oral form. The product is distributed in a single package with assigned NDC code 70000-0042-1 24 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack. 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 Code70000-0042
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.		Leader Allergy Relief D
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.		Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride
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, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
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.		Cardinal Health 110, Llc. Dba Leader
Labeler Code70000
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.		ANDA210719
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.		03-09-2020
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 Leader Allergy Relief D?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)10 MM
Imprint(s)L147
Score1

Product Packages

NDC Code 70000-0042-1

Package Description: 24 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Price per Unit: $0.59852 per EA

Product Details

What are Leader Allergy Relief D 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.

Leader Allergy Relief D 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:
  • RxCUI: 1014571 - cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1014571 - 12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 1014571 - cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet

Leader Allergy Relief D 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.

Leader Allergy Relief D 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 Ingredients (In Each Extended Release Tablet)



Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg


Purpose



Antihistamine

Nasal decongestant


Uses



  • •temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • •runny nose
  • •sneezing
  • •itchy, watery eyes
  • •itching of the nose or throat
  • •nasal congestion
  • •reduces swelling of nasal passages
  • •temporarily relieves sinus congestion and pressure
  • •temporarily restores freer breathing through the nose

Do Not Use



  • •if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
  • •if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have



  • •heart disease
  • •thyroid disease
  • •diabetes
  • •glaucoma
  • •high blood pressure
  • •trouble urinating due to an enlarged prostate gland
  • •liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are



taking tranquilizers or sedatives.


When Using This Product



  • •do not use more than directed
  • •drowsiness may occur
  • •avoid alcoholic drinks
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If



  • •an allergic reaction to this product occurs. Seek medical help right away.
  • •you get nervous, dizzy, or sleepless
  • •symptoms do not improve within 7 days or are accompanied by fever

If Pregnant Or Breast-Feeding:



  • •if breast-feeding: not recommended
  • •if pregnant: 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



  • •do not break or chew tablet; swallow tablet whole
    • adults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.adults 65 years and overask a doctorchildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
     
     
     
     
     
     
     
     

Other Information



  • •store between 20° to 25°C (68° to 77°F)
  • •do not use if blister unit is broken or torn
  • •see side panel for lot number and expiration date
  • •meets USP Dissolution Test2

Inactive Ingredients



colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Original Prescription Strength

Allergy Relief D

Cetirizine Hydrochloride, 5 mg | Pseudoephedrine Hydrochloride, 120 mg

Extended Release Tablets

Antihistamine | Nasal Decongestant

Allergy and Congestion

12-Hour Relief of:

Sneezing; Runny Nose; Sinus Pressure;

Itchy, Watery Eyes; Itchy Throat or Nose; Nasal Congestion

COMPARE TO ZYRTEC-D® active ingredients

24 EXTENDED RELEASE TABLETS

Actual Size

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* Please review the disclaimer below.