FDA Label for Fexofenadine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 60 MG 500'S COUNT
- PRINCIPAL DISPLAY PANEL - 180 MG 500'S COUNT
Fexofenadine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Aurolife Pharma, 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 60 mg:
Fexofenadine HCl USP, 60 mg
For 180 mg:
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
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 aluminium or magnesium antacids
- do not take with fruit juices (see Directions)
Stop Use And Ask 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
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 printed foil inner seal on bottle is torn or missing
- store between 20°and 25°C (68°and 77°F)
- protect from excessive moisture and light
Inactive Ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide
Questions Or Comments?
call toll free 1-866-850-2876
Principal Display Panel - 60 Mg 500'S Count
NDC 13107-066-05
*Compare to 12 Hour Allegra®
Allergy active ingredient
Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
Allergy
Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat 12 Hour
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
500 Tablets 60 mg each
Principal Display Panel - 180 Mg 500'S Count
NDC 13107-067-05
*Compare to 24 Hour Allegra®
Allergy active ingredient
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
Allergy
Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat 24 Hour
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
500 Tablets 180 mg each
* Please review the disclaimer below.