CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated
Northstar Rx LLC

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Active ingredient (in each tablet)

Cetirizine hydrochloride USP, 10 mg

Purpose

Antihistamine

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

Warnings

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 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.

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.

Directions

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

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

Inactive ingredients

corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide

Questions or comments?

call toll free 1-800-206-7821

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16714-271-02

Cetirizine Hydrochloride Tablets 10 mg

Allergy

Antihistamine

24 Hour Relief of

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

DO NOT USE IF IMPRINTED FOIL INNER SEAL ON BOTTLE IS BROKEN OR MISSING

NORTHSTAR

100 Tablets

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16714-271
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE)	CETIRIZINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN
LACTOSE MONOHYDRATE
POVIDONE K29/32
MAGNESIUM STEARATE

Product Characteristics
Color	WHITE (white to off-white)	Score	no score
Shape	CAPSULE (rounded off rectangular)	Size	9mm
Flavor		Imprint Code	S;521
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:16714-271-02	100 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC	None
2	NDC:16714-271-03	300 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078862	10/19/2009

Labeler - Northstar Rx LLC (830546433)

Revised: 09/2011 Northstar Rx LLC