Alavert allergy sinus d-12 tablet, film coated, extended release

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 25C (59 and 77F)
  • 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)

Ingredients and appearance - Product information

Alavert allergy sinus d-12 tablet, film coated, extended release- Loratadine, pseudoephedrine sulfate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 54868-3484
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loratadine ( UNII: 7AJO3BO7QN)( Loratadine - UNII: 7AJO3BO7QN ) 5 mgin 1
Pseudoephedrine sulfate ( UNII: Y9DL7QPE6B)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 120 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Calcium phosphate, dibasic, anhydrous ( UNII: L11K75P92J)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Povidone ( UNII: FZ989GH94E)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE (white to off-white) Score 1
Shape ROUND (round shape and an extra deep convex) Size 14 mm
Imprint Code Alavert;D12

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076050 USA

Labeler - Physicians Total Care, Inc.( 194123980)

Establishment

Name ID/FEI Business Operations
Physicians Total Care, Inc. 194123980 relabel( 54868-3484)

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 FACTSPanel.

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.

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146