FDA Label for Health Mart Fexofenadine Hydrochloride

View Indications, Usage & Precautions

Health Mart Fexofenadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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
  • •itchy, watery eyes
  • •sneezing
  • •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.


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 (1-800-222-1222).


Directions



adults and children 12 years of age and over

take one 180 mg 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



  • •do not use if carton is opened or printed foil under cap is broken or missing
  • •Store between 20°-25°C (68°-77°F)
  • •protect from excessive moisture
  • •this product meets the requirements of USP Dissolution Test 3

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to Allegra® Allergy active ingredient

ALLERGY

Fexofenadine Hydrochloride

Tablets, 180mg - Antihistamine

24 HR

Indoor/Outdoor Allergy Relief Of Sneezing/Runny Nose/Itchy, Watery Eyes/Itchy Nose or Throat

Gluten Free - Non-drowsy

ACTUAL SIZE

70 Tablets


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