FDA Label for Fexofenadine Hydrochloride
View Indications, Usage & Precautions
Fexofenadine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Dispensing Solutions, 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.
Active Ingredient (In Each Tablet)
Fexofenadine HCl 60 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 havekidney 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 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours |
| children under 12 years of age | do not use |
| adults 65 years of age and older | ask a doctor |
Other Information
- do not use if printed foil under cap is broken or missing
- store at 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
Otc - Questions
1-800-719-9260
Package/Label Principal Display Panel
NDC 66336-0560-XX
NDC 66336-0560-14
NDC 66336-0560-30
Compare to Allegra® Allergy active ingredient
Fexofenadine Hydrochloride Tablets, 60 mg
Antihistamine
Non-Drowsy
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat
Original Prescription Strength
12 Hour
60 mg Each
Actual Size
Indoor and Outdoor Allergies
Allergy
* Please review the disclaimer below.