ALAVERT ALLERGY SINUS D-12

Dosage form: tablet, film coated, extended release
Ingredients: loratadine 5mg, pseudoephedrine sulfate 120mg
Labeler: Wyeth Consumer Healthcare
NDC Code: 0573-2660

Alavert D-12 Hour Allergy and Sinus (Extended Release Tablets)
(loratadine and pseudoephedrine sulfate)

DRUG FACTS

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

WARNINGS

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.

ALAVERT ALLERGY SINUS D-12 
loratadine, pseudoephedrine sulfate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2660
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
loratadine (loratadine) loratadine5 mg
pseudoephedrine sulfate (pseudoephedrine) pseudoephedrine sulfate120 mg
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (round shape and an extra deep convex) Size14mm
FlavorImprint CodeAlavert;D12
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-2660-122 BLISTER PACK (BLISTER PACK) in 1 CARTON
16 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
2NDC:0573-2660-244 BLISTER PACK (BLISTER PACK) in 1 CARTON
26 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07605001/30/2004
Labeler - Wyeth Consumer Healthcare (828831730)

Revised: 02/2010
 
Wyeth Consumer Healthcare

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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