FDA Label for Fexofenadine
View Indications, Usage & Precautions
Fexofenadine Product Label
The following document was submitted to the FDA by the labeler of this product Wockhardt Usa 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)
For 30 mg:
Fexofenadine HCl 30 mg
For 60 mg:
Fexofenadine HCl 60 mg
For 180 mg:
Fexofenadine HCl 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
Other
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.
Manufactured by:
Patheon Puerto Rico, Inc.,
Manati, PR 00674
Distributed by:
Wockhardt USA LLC
20 Waterview Blvd.
Parippany, NJ 07054
USA.
Rev.06-15
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
For 30 mg:
| adults and children 12 years of age and over | take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours |
| children 6 to under 12 years of age | take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours |
| children under 6 years of age | do not use |
| adults 65 years of age and older | ask a doctor |
| consumers with kidney disease | ask a doctor |
For 60 mg:
| 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 |
| consumers with kidney disease | ask a doctor |
For 180 mg:
| 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
- safety sealed: do not use if carton is opened or if inner seal imprinted with "Sealed for Your Protection" is missing or torn
- safety sealed: do not use if carton is opened or if individual blister unit is torn or open
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
Inactive Ingredients
For 30 mg
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide
For 60 mg
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide
For 180 mg
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide
Questions Or Comments?
Call toll-free 1-800-346-6854
Package Label.Principal Display Panel
Fexofenadine hydrochloride
Film-coated Tablets
Indoor and Outdoor Allergies – 24 hours
180 mg
30 tablets bottle pack
Fexofenadine hydrochloride
Film-coated Tablets
Indoor and Outdoor Allergies – 24 hours
180 mg
90 tablets bottle pack
Fexofenadine hydrochloride
Film-coated Tablets
Indoor and Outdoor Allergies – 24 hours
180 mg
5 tablets blister carton
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