Indoor And Outdoor Allergies

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: SG;202 Shape: oval Color: pink Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2019-06-01

Medication Information

Purpose

Antihistamine

Description

(in each film-coated tablet) Fexofenadine HCl USP, 180 mg

Uses

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

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

Do Not Use

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

Questions?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

Active Ingredient

(in each film-coated tablet)

Fexofenadine HCl USP, 180 mg

Other Information

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

■ protect from excessive moisture

■ each tablet contains: sodium 8.2 mg

■ this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients

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

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)

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.

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 respiratory allergies:

■ runny nose

■ sneezing

■ itchy, watery eyes

■ itching of the nose or throat

Section 51945-4 (51945-4)

Purpose

Antihistamine

Directions

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

Do Not Use (Do not use)

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

Questions?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

Active Ingredient (Active ingredient)

(in each film-coated tablet)

Fexofenadine HCl USP, 180 mg

Other Information

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

■ protect from excessive moisture

■ each tablet contains: sodium 8.2 mg

■ this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients (Inactive ingredients)

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

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)

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, (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.

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": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE", "unii": "029TFK992N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "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 YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "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 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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "Questions?": "call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.", "Active ingredient": "(in each film-coated tablet) Fexofenadine HCl USP, 180 mg", "Other Information": "■ store between 20° and 25°C (68° and 77°F) ■ protect from excessive moisture ■ each tablet contains: sodium 8.2 mg ■ this product meets the requirements of USP Dissolution Test 2", "Inactive ingredients": "anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide and yellow iron oxide.", "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)", "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.", "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