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  5. Label Information: Alavert Allergy Sinus D-12

FDA Label for Alavert Allergy Sinus D-12

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSES
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT DO NOT TAKE MORE THAN DIRECTED.
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRODUCT PACKAGING

Alavert Allergy Sinus D-12 Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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
    • 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



  • 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.


* Please review the disclaimer below.