Fexofenadine Hydrochloride Tablets Usp, 180 Mg

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Light Mineral Oil Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 6000 Polysorbate 80 Starch, Corn Ferric Oxide Red Hypromellose 2910 (6 Mpa.s) Ferric Oxide Yellow Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: J;44 Shape: capsule Color: pink Size: 18 mm Score: 1

Marketing Status

ANDA Active Since 2019-02-18

Medication Information

Purpose

Antihistamine

How Supplied

Fexofenadine HCL, 180 mg are pink, capsules debossed with 'J 44' and are supplied as follows:

NDC 72789-196-10 in bottles of 10 tablets

NDC 72789-196-30 in bottles of 30 tablets

NDC 72789-196-90 in bottles of 90 tablets

Description

Fexofenadine hydrochloride USP, 180 mg

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

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Questions?

Call 1-800-206-7821

Other Information

• Tamper-Evident: Do not use if seal is missing from bottle.

• 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.

Principal Display Panel

Fexofenadine Hydrochloride Tablets USP, 180 mg

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)

Ask A Doctor Before Use If

you have kidney disease. Your doctor should determine if you need a different dose.

Stop Use and Ask A 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.

Keep Out of Reach of Children

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

Active Ingredient(s) in Each Tablet

Fexofenadine hydrochloride USP, 180 mg

Structured Label Content

Use(s) (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

Purpose (PURPOSE)

Antihistamine

Directions (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

Do Not Use (DO NOT USE)

if you have ever had an allergic reaction to this product or any of its ingredients.

Questions?

Call 1-800-206-7821

How Supplied (HOW SUPPLIED)

Fexofenadine HCL, 180 mg are pink, capsules debossed with 'J 44' and are supplied as follows:

NDC 72789-196-10 in bottles of 10 tablets

NDC 72789-196-30 in bottles of 30 tablets

NDC 72789-196-90 in bottles of 90 tablets

Other Information (Other information)

• Tamper-Evident: Do not use if seal is missing from bottle.

• store between 20° and 25°C (68° and 77°F)

• protect from excessive moisture

Inactive Ingredients (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Fexofenadine Hydrochloride Tablets USP, 180 mg

When Using This Product (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)

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

you have kidney disease. Your doctor should determine if you need a different dose.

Stop Use and Ask A Doctor If (STOP USE AND ASK A 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.

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.

Active Ingredient(s) in Each Tablet (ACTIVE INGREDIENT(S) in each tablet)

Fexofenadine hydrochloride USP, 180 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "PURPOSE": "Antihistamine", "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", "DO NOT USE": " if you have ever had an allergic reaction to this product or any of its ingredients. ", "Questions?": "Call 1-800-206-7821", "HOW SUPPLIED": "Fexofenadine HCL, 180 mg are pink, capsules debossed with 'J 44' and are supplied as follows: NDC 72789-196-10 in bottles of 10 tablets NDC 72789-196-30 in bottles of 30 tablets NDC 72789-196-90 in bottles of 90 tablets", "Other information": " • Tamper-Evident: Do not use if seal is missing from bottle. • 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.", "PRINCIPAL DISPLAY PANEL": "Fexofenadine Hydrochloride Tablets USP, 180 mg", "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)", "ASK A DOCTOR BEFORE USE IF": "you have kidney disease. Your doctor should determine if you need a different dose.", "STOP USE AND ASK A 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.", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center right away.", "ACTIVE INGREDIENT(S) in each tablet": "Fexofenadine hydrochloride USP, 180 mg"}

Fexofenadine Hydrochloride Tablets Usp, 180 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information