ALAVERT ALLERGY SINUS D-12 - loratadine and pseudoephedrine sulfate tablet, film coated, extended release 
Wyeth Consumer Healthcare

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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

WARNINGS

Do not use

Ask a doctor before use if you have

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

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

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

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 NEW COLD USE

ALAVERT D-12 HOUR allergy & sinus

Loratadine 5mg/Antihistamine

Pseudoephedrine Sulfate 120mg/Nasal Decongestant

Non-Drowsy*

Allergy & Sinus Relief

Cold Relief for

12 Extended Release Tablets

*When taken as directed. See DRUG FACTS Panel.

www.alavert.com

Wyeth

Distributed by:

Wyeth Consumer Healthcare

Madison, NJ 07940

©2004

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

ALAVERT D-12 HOUR allergy & sinus Packaging

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 CARTRIDGE contains a BLISTER PACK
2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTRIDGE (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: 06/2009 Wyeth Consumer Healthcare