Fexofenadine Hydrochloride Tablet, Film Coated
FDA Label NDC 46122-779

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Fexofenadine Hydrochloride (NDC 46122-779). 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 other, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Uses

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ When Using This Product

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 180 Mg Tablet Bottle Carton

Other

Drug Facts

Distributed By:
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428

Active Ingredient (In Each Tablet)

Fexofenadine HCl, USP 180 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

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

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)

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 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 inner safety seal is torn or missing
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive Ingredients

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide