Active Ingredient
(in each film-coated tablet)
Fexofenadine HCl USP, 180 mg
Fexofenadine Hydrochloride
FDA Label NDC 68016-769
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Fexofenadine Hydrochloride (NDC 68016-769). 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, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
■ sneezing
■ itchy, watery eyes
■ itching of the nose or throat
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 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours
- do not use
- ask a doctor
- ask a doctor
children under 12 years of age
adults 65 years of age and older
consumers with kidney disease
Other Information
■ store between 20° and 25°C (68° and 77°F)
■ protect from excessive moisture
■ each tablet contains: sodium 8.2 mg
■ this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide and yellow iron oxide.
Questions?
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
Package Label.Principal Display Panel
15 Count (300000433 R00 Final)
30 Count (300000434 R00 Final)
45 Count (300000436 R00 Final)
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