DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Anhydrous Lactose Silicon Dioxide Croscarmellose Sodium Hypromelloses Lactose Monohydrate Starch, Pregelatinized Corn Stearic Acid Ferric Oxide Red Ferric Oxide Yellow Polyethylene Glycol 400 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: E;44 Shape: capsule Color: orange Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2015-01-15

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper resporatory alleergies:

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

Warnings

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

Other Information

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

Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions Or Comments?

call 1-855-274-4122

Principal Display Panel

NDC 55315-355-31

Original Prescription Strength

Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hours Relief of:

Sneezing

R unny nose

Itchy, Watery Eyes

Itchy Nose or Throat

DO NOT USE IF FOIL SEAL IS TORN OR MISSING

30 Tablets 180 mg each

When Using This Product

do not take more than directed
do not take at the same time as aluminium or magnesium antacids
do not take with fruit juices (see directions)

Stop Use and Ask 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(in Each Tablet)

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have

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

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper resporatory alleergies:

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

Purpose

Antihistamine

Warnings

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

Principal Display Panel

NDC 55315-355-31

Original Prescription Strength

Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hours Relief of:

Sneezing

R unny nose

Itchy, Watery Eyes

Itchy Nose or Throat

DO NOT USE IF FOIL SEAL IS TORN OR MISSING

30 Tablets 180 mg each

When Using This Product (When using this product)

do not take more than directed
do not take at the same time as aluminium or magnesium antacids
do not take with fruit juices (see directions)

Stop Use and Ask Doctor If (Stop use and ask doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding (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(in Each Tablet) (Active ingredient(in each tablet))

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Advanced Ingredient Data

[{"name": "FEXOFENADINE", "unii": "E6582LOH6V", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, PREGELATINIZED CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper resporatory alleergies: 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", "Other information": "safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing store between 20°and 25°C (68°and 77°F) protect from excessive moisture and light", "Inactive ingredients": "anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,", "Questions or comments?": " call 1-855-274-4122", "Principal Display Panel": "NDC 55315-355-31 Original Prescription Strength Non-Drowsy Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine Allergy Indoor & Outdoor Allergies 24 Hours Relief of: Sneezing R unny nose Itchy, Watery Eyes Itchy Nose or Throat DO NOT USE IF FOIL SEAL IS TORN OR MISSING 30 Tablets 180 mg each", "When using this product": "do not take more than directed do not take at the same time as aluminium or magnesium antacids do not take with fruit juices (see directions)", "Stop use and ask 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(in each tablet)": "Fexofenadine HCl USP, 180 mg", "Ask a doctor before use if you have": "kidney disease. Your doctor should determine if you need a different dose."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information