Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 mg)

Inactive Ingredients

Anhydrous Lactose Silicon Dioxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: M;C37 Shape: round Color: white Size: 6 mm Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2007-12-27

Medication Information

Purpose

Antihistamine

Description

Cetirizine hydrochloride USP, 5 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

PRINCIPAL DISPLAY PANEL - 5 mg Allergy

NDC 0378-3635-01

Cetirizine HCl

Tablets, USP

Allergy

5 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

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

RMX-AR3635A 100 Tablets

Tamper Evident: do not use if foil seal

under cap is missing, open or broken.

Directions

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Do Not Use

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

Questions?

Call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505

Other Information

•
store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

When Using This Product

•
drowsiness may occur
•
avoid alcoholic drinks
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
be careful when driving a motor vehicle or operating machinery

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 breast-feeding: not recommended
•
if pregnant: 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)

Cetirizine hydrochloride USP, 5 mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

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)

PRINCIPAL DISPLAY PANEL - 5 mg Allergy

NDC 0378-3635-01

Cetirizine HCl

Tablets, USP

Allergy

5 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

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

RMX-AR3635A 100 Tablets

Tamper Evident: do not use if foil seal

under cap is missing, open or broken.

Purpose

Antihistamine

Directions

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or 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 or to an antihistamine containing hydroxyzine.

Questions?

Call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505

Other Information (Other information)

•
store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

When Using This Product (When using this product)

•
drowsiness may occur
•
avoid alcoholic drinks
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
be careful when driving a motor vehicle or operating machinery

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:)

•
if breast-feeding: not recommended
•
if pregnant: 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))

Cetirizine hydrochloride USP, 5 mg

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

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information