ALLERGY RELIEF- cetirizine hydrochloride tablet
Western Family Foods Inc

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Western Family Allergy Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 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. (1-800-222-1222)

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

do not use if printed foil under cap is broken or missing
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

INDOOR & OUTDOOR ALLERGIES

Allergy

RELIEF

CETIRIZINE HYDROCHLORIDE TABLETS 10mg/Antihistamine

ALLERGY

24 HOUR RELIEF OF:

SNEEZING

RUNNY NOSE

ITCHY, WATERY EYES

ITCHY THROAT OR NOSE

Actual Size

Gluten Free

ORIGINAL PRESCRIPTION STRENGTH

COMPARE TO THE ACTIVE INGREDIENT OF ZYRTEC®

Allergy Carton Image 1

Allergy Carton Image 2

ALLERGY RELIEF
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:55312-458
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
POVIDONE
TITANIUM DIOXIDE
TRIACETIN

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	4H2
Contains

#	Item Code	Package Description
Packaging
1	NDC:55312-458-66	1 in 1 CARTON
1		14 in 1 BLISTER PACK
2	NDC:55312-458-76	1 in 1 CARTON
2		120 in 1 BOTTLE
3	NDC:55312-458-72	1 in 1 CARTON
3		60 in 1 BOTTLE
4	NDC:55312-458-39	1 in 1 CARTON
4		30 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078336	01/25/2008

Labeler - Western Family Foods Inc (192166072)

Revised: 5/2009

Document Id: 32df4f24-05c3-4798-9e53-46760f9b7da9

Set id: 32df4f24-05c3-4798-9e53-46760f9b7da9

Version: 1

Effective Time: 20090526

Western Family Foods Inc