Topco Associates Llc. Allergy Relief Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Croscarmellose Sodium Fd&c Blue No. 2 Fd&c Red No. 40 Fd&c Yellow No. 6 Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: L847 Shape: oval Color: pink Size: 18 mm Score: 1

Marketing Status

ANDA Completed Since 2021-08-23 Until 2023-12-31

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl 180 mg

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

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

•
do not use if printed blister unit is broken or torn
•
store between 20° -25°C (68° -77°F)
•
protect from excessive moisture
•
this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions Or Comments?

1-888-423-0139

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 (1-800-222-1222).

Active Ingredient (in Each Tablet)

Fexofenadine HCl 180 mg

Ask A Doctor Before Use If You Have

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

Package/label Principal Display Panel

COMPARE TO ALLEGRA^® ALLERGY ACTIVE INGREDIENT

NON-DROWSY

Allergy Relief

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg (ANTIHISTAMINE)

24 HR

INDOOR/OUTDOOR ALLERGY RELIEF

- Sneezing – Runny Nose

- Itchy, Watery Eyes

- Itchy Nose or Throat

5 TABLETS

actual size

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

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 (Do not use)

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

Other Information (Other information)

•
do not use if printed blister unit is broken or torn
•
store between 20° -25°C (68° -77°F)
•
protect from excessive moisture
•
this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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 (1-800-222-1222).

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

Fexofenadine HCl 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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

COMPARE TO ALLEGRA^® ALLERGY ACTIVE INGREDIENT

NON-DROWSY

Allergy Relief

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg (ANTIHISTAMINE)

24 HR

INDOOR/OUTDOOR ALLERGY RELIEF

- Sneezing – Runny Nose

- Itchy, Watery Eyes

- Itchy Nose or Throat

5 TABLETS

actual size

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", "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": "• do not use if printed blister unit is broken or torn • store between 20° -25°C (68° -77°F) • protect from excessive moisture • this product meets the requirements of USP Dissolution Test 2", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide", "Questions or comments?": "1-888-423-0139", "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 (1-800-222-1222).", "Active ingredient (in each tablet)": "Fexofenadine HCl 180 mg", "Ask a doctor before use if you have": "kidney disease. Your doctor should determine if you need a different dose.", "Package/Label Principal Display Panel": "COMPARE TO ALLEGRA ® ALLERGY ACTIVE INGREDIENT NON-DROWSY Allergy Relief FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg (ANTIHISTAMINE) 24 HR INDOOR/OUTDOOR ALLERGY RELIEF - Sneezing – Runny Nose - Itchy, Watery Eyes - Itchy Nose or Throat 5 TABLETS actual size"}

Topco Associates Llc. Allergy Relief Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information