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 Big Lots Stores, 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 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
■ 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.
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 over
- take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours
- do not use
- ask a doctor
- ask a doctor
children under 12 years of age
adults 65 years of age and older
consumers with kidney disease
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 USP Dissolution Test 2
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 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
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