CETIRIZINE HYDROCHLORIDE TABLETS

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Drug Facts

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Cetirizine HCl, USP 5 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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.

ASK DOCTOR

OTC - ASK DOCTOR SECTION

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

ASK DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

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

OTC - STOP USE SECTION

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

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding :

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and over	1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
Adults 65 years and over	1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
Children under 6 years of age	ask a doctor
Consumers with liver or kidney disease	ask a doctor

OTHER INFORMATION

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Other information

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

OTC - QUESTIONS

OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM - 5PM EST.

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Distributed by: 
Amneal Pharmaceuticals LLC
Bridgewater, NJ08807

Rev. 07-2024-02

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Every source-derived product name is available through these pages.

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• Cetirizine Hydrochloride
• Cetirizine
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• POLYVINYL ALCOHOL, UNSPECIFIED
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POVIDONE
• STARCH, CORN
• TALC
• TITANIUM DIOXIDE

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