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  5. Label Information: Fexofenadine Hydrochloride

FDA Label for Fexofenadine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. WHEN USING THIS PRODUCT
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 180 MG TABLET BOTTLE CARTON

Fexofenadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Ohm Laboratories 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.

Other



Drug Facts

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
MADE IN INDIA


Active Ingredient (In Each 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

Otc - Do Not Use



Do not use if you have ever had an allergic reaction to this product or any of its ingredients


Otc - Ask Doctor



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)

Otc - Stop Use



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


Directions



adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other Information



  • safety sealed: do not use if carton is opened or if inner safety seal is torn or missing
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive Ingredients



croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide


Questions Or Comments?



Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.


Principal Display Panel - 180 Mg Tablet Bottle Carton



†Compare To
the active ingredient of
Allegra® Allergy

NDC 51660-998-30

NDC 51660-998-55

NON-DROWSY

Fexofenadine Hydrochloride
Tablets, USP 180 mg

Antihistamine

Indoor and Outdoor Allergies

ALLERGY

24 Hour
Relief of:

* Please review the disclaimer below.