Fexofenadine Hydrochloride
FDA Label NDC 54868-6289

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Fexofenadine Hydrochloride (NDC 54868-6289). 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), warnings, do not use, ask a doctor before use if, when using this product, stop use and ask doctor if, 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)

→ Warnings

→ 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

→ Storage

→ Inactive Ingredients

→ Questions

→ Other

→ Principal Display Panel

Active Ingredient(S)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(S)

temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:

runny nose
itchy, watery eys
sneezing
itching of the nose or Throad

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 doctorshould 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

Allergy

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

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 individual blister units are torn or opened.

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.