Active Ingredient (In Each Caplet)
Fexofenadine HCl USP 180 mg
Fexofenadine Hydrochloride Tablet, Film Coated
FDA Label NDC 68210-2210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Fexofenadine Hydrochloride (NDC 68210-2210). 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 caplet), purpose, uses, do not use if, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant and 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 And 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. 1-800-222-1222
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
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
■ store between 20°and 25°C (68°and 77°F)
■ protect from excessive moisture
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 Or Comments?
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Compare to the active ingredient
in Allegra® Allergy 24 Hour†
oroginal prescription strength
ALLERGY RELIEF
Fexofenadine HCl
tablets USP 180 mg /
antihistamine
indoor & outdoor allergies
ALLERGY RELIEF
24 hour relief of:
• sneezing • runny nose
• itchy, watery eyes
• itchy nose or throat
* Please review the disclaimer below.
