FDA Label for Fexofenadine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- 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?
- PACKAGE LABEL - 30 COUNT CARTON
- PACKAGE LABEL - 30 COUNT BOTTLE
Fexofenadine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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 USP, 180 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 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 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 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
- this product meets the requirements of USP Dissolution Test 4
Inactive Ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titantium dioxide
Questions?
call 1-888-375-3784
Package Label - 30 Count Carton
MAJOR
COMPARE TO active ingredient of
ALLEGRA® ALLERGY 24 HOUR TABLETS*
NDC 0904-6711-46
Original Prescription Strength
FEXOFENADINE
HYDROCHLORIDE Tablets USP, 180 mg
Antihistamine
ALLERGY
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
Non-Drowsy
Indoor & Outdoor
Allergies
24
HOUR
30 TABLETS
180 mg EACH
Package Label - 30 Count Bottle
MAJOR NDC 0904-6711-46
Original Prescription Strength
FEXOFENADINE
HYDROCHLORIDE
Tablets USP, 180 mg / Antihistamine
ALLERGY
Indoor & Outdoor Allergies
Non-Drowsy
24
HOUR
30 TABLETS
180 mg EACH
* Please review the disclaimer below.