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

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

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

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 TypeHUMAN OTC DRUGNDC Product Code (Source)0573-2660
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
loratadine (loratadine) loratadine5 mg
pseudoephedrine sulfate (pseudoephedrine) pseudoephedrine sulfate120 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorWHITE (white to off-white) Score no score
ShapeROUND (round shape and an extra deep convex) Size14mm
FlavorImprint Code Alavert;D12
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-2660-122 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
16 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (0573-2660-12)
20573-2660-244 BLISTER PACK In 1 CARTRIDGEcontains a BLISTER PACK
26 TABLET In 1 BLISTER PACKThis package is contained within the CARTRIDGE (0573-2660-24)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07605001/30/2004

Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 06/2009Wyeth Consumer Healthcare