Fexofenadine Hydrochloride Tablet
FDA Label NDC 84324-045

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Fexofenadine Hydrochloride (NDC 84324-045). 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, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Fexofenadine HCl 60 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.

Directions

 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

Other Information

■ Store between 20°to 25°C (68°to 77°F)

■ Protect from excessive moisture

Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch, red iron oxide, stearic acid, titanium dioxide, yellow iron oxide.

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