Fexofenadine Hydrochloride Tablets, Usp 180 Mg

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Croscarmellose Sodium Starch, Corn Magnesium Stearate Hypromellose, Unspecified Titanium Dioxide Polyethylene Glycol 400 Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: 545 Shape: oval Color: pink Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2022-04-29

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

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

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50569-3

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

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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 inner safety seal is torn or missing
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive Ingredients

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions Or Comments?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

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)

Active Ingredient (in Each Tablet)

Fexofenadine HCl, USP 180 mg

Principal Display Panel 180 Mg Tablet Bottle Carton

^†Compare To

the active ingredient of

Allegra^® Allergy

NDC 51660-998-30

NDC 51660-998-55

NON-DROWSY

Fexofenadine Hydrochloride

Tablets, USP 180 mg

Antihistamine

Indoor and Outdoor Allergies

ALLERGY

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

ohm^®

30 Tablets

DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH

"SEALED for YOUR PROTECTION" IS TORN OR MISSING

Structured Label Content

Uses

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

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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

Other Information (Other information)

safety sealed: do not use if carton is opened or if inner safety seal is torn or missing
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

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)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl, USP 180 mg

Principal Display Panel 180 Mg Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton)

^†Compare To

the active ingredient of

Allegra^® Allergy

NDC 51660-998-30

NDC 51660-998-55

NON-DROWSY

Fexofenadine Hydrochloride

Tablets, USP 180 mg

Antihistamine

Indoor and Outdoor Allergies

ALLERGY

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

ohm^®

30 Tablets

DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH

"SEALED for YOUR PROTECTION" IS TORN OR MISSING

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50569-3": "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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", "Other information": "safety sealed: do not use if carton is opened or if inner safety seal is torn or missing store between 20° to 25°C (68° to 77°F) protect from excessive moisture", "Inactive ingredients": "croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide", "Questions or comments?": "Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555 .", "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 )", "Active ingredient (in each tablet)": "Fexofenadine HCl, USP 180 mg", "PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton": "† Compare To the active ingredient of Allegra ® Allergy NDC 51660-998-30 NDC 51660-998-55 NON-DROWSY Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine Indoor and Outdoor Allergies ALLERGY 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat ohm ® 30 Tablets DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH "SEALED for YOUR PROTECTION" IS TORN OR MISSING"}

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