Fexofenadine Hydrochloride
FDA Label NDC 68554-5061

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hetero Labs Limited for the product Fexofenadine Hydrochloride (NDC 68554-5061). 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(s), purpose, use(s), do not use, ask a doctor before use if, when using this product, stop use and ask doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Do Not Use

→ Ask A Doctor Before Use If

→ When Using This Product

→ Stop Use And Ask Doctor If

→ Pregnancy/breastfeeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

Active Ingredient(S)

(in each tablet)
Fexofenadine Hydrochloride USP, 30 mg
Fexofenadine Hydrochloride USP, 60 mg
Fexofenadine Hydrochloride USP, 180 mg

Purpose

Antihistamine

Use(S)

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 Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy/Breastfeeding

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

30 mg

adults and children 12 years of age and over	take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age	take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 6 years of age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

60 mg

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

180 mg

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

Tamper Evident: Do not use if printed foil seal under cap is missing
This unit-dose package is not child-resistant
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture

Inactive Ingredients

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.