Alavert D-12 Hour Allergy and Sinus

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

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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

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 # NDC Package Description Multilevel Packaging 1 0573-2660-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2660-12) 2 0573-2660-24 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2660-24)

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: 02/2010Wyeth Consumer Healthcare

More Alavert D-12 Hour Allergy and Sinus resources

• Alavert D-12 Hour Allergy and Sinus Side Effects (in more detail)
• Alavert D-12 Hour Allergy and Sinus Use in Pregnancy & Breastfeeding
• Alavert D-12 Hour Allergy and Sinus Drug Interactions
• Alavert D-12 Hour Allergy and Sinus Support Group
• 0 Reviews for Alavert D-12 Hour Allergy and Sinus - Add your own review/rating

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