Active Ingredient (In Each Tablet)
Fexofenadine HCl USP, 180 mg
Fexofenadine Hydrochloride Tablet
FDA Label NDC 0904-6711
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Fexofenadine Hydrochloride (NDC 0904-6711). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Carton (Carton)
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
Bottle (Bottle)
* Please review the disclaimer below.
