NDC 0573-2660 Alavert Allergy Sinus D-12
Loratadine, Pseudoephedrine Sulfate Tablet, Film Coated, Extended Release Oral

Product Information

Alavert Allergy Sinus D-12 is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Alavert Allergy Sinus D-12 is loratadine, pseudoephedrine sulfate. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Product Code0573-2660
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.
Alavert Allergy Sinus D-12
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.
Loratadine, Pseudoephedrine Sulfate
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.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0573
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.
ANDA076050
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.
01-30-2004
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.
12-31-2022
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 Alavert Allergy Sinus D-12?


Product Characteristics

Color(s)WHITE (C48325 - WHITE TO OFF-WHITE)
ShapeROUND (C48348)
Size(s)14 MM
Imprint(s)ALAVERT;D12
Score1

Product Packages

NDC 0573-2660-12

Package Description: 2 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Price per Unit: $0.53781 per EA

NDC 0573-2660-24

Package Description: 4 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Price per Unit: $0.53781 per EA

Product Details

What are Alavert Allergy Sinus D-12 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.
  • LORATADINE 5 mg/1 - A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.
  • PSEUDOEPHEDRINE SULFATE 120 mg/1

Alavert Allergy Sinus D-12 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: 1242399 - pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1242399 - 12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet
  • RxCUI: 1242399 - loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 1242401 - Alavert D 5 MG / 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1242401 - 12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Alavert D]

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

Loratadine

Loratadine is pronounced as (lor at' a deen)

Why is loratadine medication prescribed?
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include ...
[Read More]
Pseudoephedrine

Pseudoephedrine is pronounced as (soo doe e fed' rin)
Why is pseudoephedrine medication prescribed?
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseud...
[Read More]

* Please review the disclaimer below.

Alavert Allergy Sinus D-12 Labeling and Warnings

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.

Table of Contents



Active Ingredients (In Each Tablet)



Loratadine 5 mg

Pseudoephedrine sulfate 120 mg


Purposes



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
    • temporarily relieves nasal congestion due to the common cold, hay fever or other respiratory allergies
    • 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
  • 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • liver or kidney disease. Your doctor should determine if you need a different dose.

When Using This Product Do Not Take More Than Directed.



Taking more than directed may cause drowsiness.


Stop Use And Ask A Doctor If



  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • nervousness, dizziness or sleeplessness occurs

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



  • do not divide, crush, chew or dissolve the tablet
  • AgeDose
    adults and children 12 years and over
    1 tablet every 12 hours; not more than 2 tablets in 24 hours
    children under 12 years of age ask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information



  • each tablet contains: calcium 30 mg
  • store between 15° and 25°C (59° and 77°F)
  • keep in a dry place

Inactive Ingredients



croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide


Questions Or Comments?



Call weekdays from 9 AM to 5 PM EST at 1-800-ALAVERT (1-800-252-8378)


Product Packaging



The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

SEE COLD USE

ALAVERT D-12 HOUR allergy & sinus

Loratadine 5mg/Antihistamine

Pseudoephedrine Sulfate 120mg/Nasal Decongestant

Non-Drowsy*

*When taken as directed. See DRUG FACTS Panel.

Allergy & Sinus Relief

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Nasal Congestion
  • Sinus Pressure
  • Cold Symptom Relief for

    • Nasal Congestion
    • Sinus Pressure
    • Compare to Claritin & SAVE!

      Claritin is a registered trademark of Schering Corporation

      12 Extended Release Tablets

      For most recent product information, visit www.alavert.com

      Wyeth

      Distributed by:

      Wyeth Consumer Healthcare

      Madison, NJ 07940

      ©2009 Wyeth

      EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.


* Please review the disclaimer below.