Allergy Relief Tablet
FDA Label NDC 84324-040

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 Allergy Relief (NDC 84324-040). 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Tablet)

Fexofenadine HCl 180 mg

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

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.

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

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

■ Protect from excessive moisture

Inactive Ingredients

Microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearte, hypromellose, lactose monohydrate, polyethylene glycol 6000, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide

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