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  5. Label Information: Fexofenadine Hcl

FDA Label for Fexofenadine Hcl

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    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?
    14. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Fexofenadine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Advanced Rx 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 Ingredient (In Each Tablet)



Fexofenadine HCl 180 mg


Purpose



Antihistamine


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

Do Not Use



if you have ever had an allergic reaction to this product or any of its ingredients.


Ask A Doctor Before Use If You Have



kidney disease. Your doctor should determine if you need a different dose.


When Using This Product



  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)

Stop Use And Ask A Doctor If



an allergic reaction to this product occurs. Seek medical help right away.


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 (1-800-222-1222) right away.


Directions



adults and children 12 years of age and over

take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor


Other Information



  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains:sodium 8.2 mg
  • this product meets the requirements of USPDissolution Test 2
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients



anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide


Questions?



call toll free 1-800-630-8895


Package/Label Principal Display Panel



NDC 80513-506-01

Compare to the active ingredient in Allegra ®Allergy 24 Hour Tablets *

Non-Drowsy

Allergy Relief

Fexofenadine HCL 180 mg

INDOOR & OUTDOOR ALLERGY

24-Hour Allergy Relief Of:

  • Sneezing, runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

    • 100 Tablets

    *This product is not manufactured or distributed by the owner of the registered trademark Allegra ®Allergy 24 Hour Tablets.

    label - fexofenadine allergy label

    label - fexofenadine allergy label


* Please review the disclaimer below.