Understanding and controlling your respiratory allergies

Alavert D-12 Hour Allergy and Sinus

Generic Name: loratadine, pseudoephedrine sulfate
Dosage Form: tablet, film coated, extended release

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

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine 5 mg

Slideshow: Top Prevention Tips - Springtime Allergies

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
Age Dose
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 disease ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2660
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
loratadine (loratadine) loratadine 5 mg
pseudoephedrine sulfate (pseudoephedrine) pseudoephedrine sulfate 120 mg
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (round shape and an extra deep convex) Size 14mm
Flavor Imprint Code Alavert;D12
Contains         
Packaging
# Item Code Package Description
1 NDC:0573-2660-12 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 6 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
2 NDC:0573-2660-24 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 6 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076050 01/30/2004
Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 02/2010
 
Wyeth Consumer Healthcare



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