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  5. Label Information: Fexofenadine Hcl

FDA Label for Fexofenadine Hcl

View Indications, Usage & Precautions

Table of Contents

    1. ALLERGYACTIVE INGREDIENT (IN EACH FILM-COATED TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. CAMBER CONSUMER CARE - COMPARE TO THE ACTIVE INGREDIENT IN ALLEGRA® ALLERGY 24 HOUR TABLETS ALLERGY RELIEF - 24 HOUR FEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 MG ANTIHISTAMINE INDOOR & OUTDOOR ALLERGIES

Fexofenadine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Nucare Pharmaceuticals,inc.. 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.

Allergyactive Ingredient (In Each Film-Coated Tablet)



Fexofenadine HCl USP, 180 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Warnings




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.


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



 adults and children 12 years of age and overtake 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



  • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
  • 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 USP Dissolution Test 2

Inactive Ingredients



anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.


Questions Or Comments?



Call 1-888-588-1418

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA,

Made in USA


Camber Consumer Care - Compare To The Active Ingredient In Allegra® Allergy 24 Hour Tablets Allergy Relief - 24 Hour Fexofenadine Hydrochloride Tablets Usp, 180 Mg Antihistamine Indoor & Outdoor Allergies



pdp - 68071 4568 09 C119

pdp - 68071 4568 09 C119


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