Cetirizine Hydrochloride

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Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl, USP 10 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USES

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

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

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

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

• 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

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: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over: ask a doctor

children under 6 years of age: ask a doctor

consumers with liver or kidney disease: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.(for bottle cartons/stand-alone labels only)
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.(for blister cartons only)
• store between 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

call 1-800-406-7984

KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

^†Compare to the active ingredient of Zyrtec^®

NDC 63187-110-90

Original Prescription Strength

Cetirizine HCl Tablets, 10 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hour

Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

90 TABLETS 10 mg EACH

^†This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec^®. Zyrtec^® is a registered trademark of UCB Pharma, S.A.

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Products#

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

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

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Ingredients#

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Product history page 1 of 5 · 172 observed states.

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