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 
Physicians Total Care, Inc.

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DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

PURPOSES

Antihistamine

Nasal decongestant

USES

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

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 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

Cold Symptom Relief for

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.

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

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 DRUGItem Code (Source)NDC:54868-3484(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
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONE 
TITANIUM DIOXIDE 
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
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54868-3484-04 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
16 TABLET, FILM COATED, EXTENDED RELEASE ( TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (54868-3484-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07605004/26/200706/30/2012

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 09/2012 Physicians Total Care, Inc.