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  5. Label Information: Alavert Allergy And Congestion D-12 Hour

FDA Label for Alavert Allergy And Congestion D-12 Hour

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - WHEN USING
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 24 TABLET BLISTER PACK CARTON

Alavert Allergy And Congestion D-12 Hour Product Label

The following document was submitted to the FDA by the labeler of this product Foundation Consumer Brands. 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.

Other



Drug Facts

Distributed by: Foundation Consumer Brands, LLC
Pittsburgh, PA 15212


Otc - Purpose



Active ingredients (in each tablet)Purposes
Loratadine 5 mgAntihistamine
Pseudoephedrine sulfate 120 mgNasal decongestant

Uses



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itchy, watery eyes
    • runny nose
    • itching of the nose or throat
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper 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
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - When Using



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



  • do not divide, crush, chew or dissolve the tablet
    • adults and children 12 years and over1 tablet every 12 hours; not more than 2 tablets in 24 hours
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information



  • each tablet contains: calcium 25 mg
  • store between 20° to 25°C (68° to 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 1-800 ALAVERT (1-800-252-8378) weekdays 9 AM to 5 PM EST


Principal Display Panel - 24 Tablet Blister Pack Carton



Compare ours to the Active Ingredients in
Claritin-D® 12 Hour Tablets†

allergy & congestion

ALAVERT®
D-12
HOUR

Pseudoephedrine Sulfate 120 mg/Nasal Decongestant
Loratadine 5 mg/Antihistamine – Extended Release Tablets

Non-Drowsy*
Relief of:
• Nasal and Sinus Congestion Due to Colds or Allergies
• Sneezing  • Runny Nose  • Itchy, Watery Eyes
• Itchy Throat or Nose Due to Allergies

Indoor & Outdoor Allergies
*When taken as directed. See Drug Facts Panel.

24 TABLETS

Actual Size

Principal Display Panel - 24 Tablet Blister Pack Carton - alavert 01

Principal Display Panel - 24 Tablet Blister Pack Carton - alavert 01


* Please review the disclaimer below.