Fexofenadine Hydrochloride Tablets Usp, 180 Mg

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Anhydrous Lactose Silicon Dioxide Starch, Corn Croscarmellose Sodium Hypromellose, Unspecified Lactose Monohydrate Polyethylene Glycol, Unspecified Ferric Oxide Red Stearic Acid Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: SG;202 Shape: capsule Color: pink Size: 18 mm Score: 1

Marketing Status

ANDA Active Since 2020-09-09

Medication Information

Purpose

Antihistamine

How Supplied

Fexofenadine Hydrochloride Tablets, USP 180 mg 30 CT NDC: 71399-8042-3 Fexofenadine Hydrochloride Tablets, USP 180 mg 100 CT NDC: 71399-8042-1

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

Section 51945-4

Directions

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

Do Not Use

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

Other Information

Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture

How Supplied Section

Fexofenadine Hydrochloride Tablets, USP 180 mg 30 CT

NDC: 71399-8042-3

Fexofenadine Hydrochloride Tablets, USP 180 mg 100 CT

NDC: 71399-8042-1

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.

Questions or Comments

Call weekdays 8.30 AM to 4.30 PM EST Please Call 1(877) 225-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

Manufactured in U.S.A

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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Antihistamine

Directions (DIRECTIONS)

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

Do Not Use (DO NOT USE)

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

Other Information (OTHER INFORMATION)

Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture

How Supplied Section (HOW SUPPLIED SECTION)

Fexofenadine Hydrochloride Tablets, USP 180 mg 30 CT

NDC: 71399-8042-3

Fexofenadine Hydrochloride Tablets, USP 180 mg 100 CT

NDC: 71399-8042-1

Inactive Ingredients (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.

Questions or Comments (QUESTIONS OR COMMENTS)

Call weekdays 8.30 AM to 4.30 PM EST Please Call 1(877) 225-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

Manufactured in U.S.A

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": "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", "DO NOT USE": " if you have ever had an allergic reaction to this product or any of its ingredients. ", "OTHER INFORMATION": "Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing. store between 20° and 25°C (68° and 77°F) protect from excessive moisture", "HOW SUPPLIED SECTION": "Fexofenadine Hydrochloride Tablets, USP 180 mg 30 CT NDC: 71399-8042-3 Fexofenadine Hydrochloride Tablets, USP 180 mg 100 CT NDC: 71399-8042-1", "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.", "QUESTIONS OR COMMENTS": "Call weekdays 8.30 AM to 4.30 PM EST Please Call 1(877) 225-6999 Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 Manufactured in U.S.A", "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