Fexofenadine Hcl Tablet, Film Coated
FDA Label NDC 50228-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sciegen Pharmaceuticals, Inc. for the product Fexofenadine Hcl (NDC 50228-201). 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 hivesactive ingredient (in each film-coated tablet), purpose, indications & usage, otc - when using, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Hivesactive Ingredient (in Each Film-coated Tablet)

→ Purpose

→ Indications & Usage

→ Otc - When Using

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions (for 60mg)

→ Directions (for 180mg)

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Allergyactive Ingredient (in Each Film-coated Tablet)

→ Uses

→ Package Label.principal Display Panel

→ Package/label Principal Display Panel

Hivesactive Ingredient (In Each Film-Coated Tablet)

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

Indications & Usage

Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Otc - When Using

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

trouble swallowing
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
trouble speaking
drooling
wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health profession immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do Not Use

to prevent hives from any known cause such as:

foods
insect stings
medicines
latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

•If you have ever had an allergic reaction to this product or any of its ingredients

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.
hives that are an unusual color, look bruised or blistered
hives that do not itch

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)

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 A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve after 3 days of treatment
the hives have lasted more than 6 weeks

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.

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (For 60Mg)

adults and children 12 years of age and over	take one 60mg 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

adults and children 12 years of age and over	take one 60mg 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

Directions (For 180Mg)

adults and children 12 years of age and over	take one 180mg 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

adults and children 12 years of age and over	take one 180mg 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° and 25°C (68° and 77°F)
protect from excessive moisture
each tablet contains: sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
this product meets the requirements of USP Dissolution Test 2
Tamper Evident: Do not use if imprinted inner safety seal is torn or missing

store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
each tablet contains: sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
this product meets the requirements of USP Dissolution Test 2
Tamper Evident: Do not use if imprinted inner safety seal is torn or missing

Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.