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 Granules India Ltd. 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(S)
Fexofenadine HCl USP 60 mg (for 60 mg)
Fexofenadine HCl USP 180 mg (for 180 mg)
Purpose
Antihistamine
Use(S)
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, water 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 over | take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)
take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) |
| 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 foil printed with granules logo under bottle cap is opened or torn.
- Do not use if carton is opened or if individual blister units are torn or opened.
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.
Questions Or Comments
Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Manufactured By:
Granules India Limited
Hyderabad-500 081, India
MADE IN INDIA
Distributed By:
Granules USA, Inc.
Parsippany, NJ 07054
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