CETIRIZINE HYDROCHLORIDE tablet, chewable

Active Ingredient in each chewable tablet

For 5 mg:

Cetirizine hydrochloride 5 mg

For 10 mg:

Cetirizine hydrochloride 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 reactions 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 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 the reach of children

In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Directions

For Cetirizine Hydrochloride Chewable Tablets, 5 mg

adults and children 6 years	1 to 2 tablets once daily depending upon severity of symptoms; do not take
and over	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	ask a doctor
age
consumers with liver or	ask a doctor
kidney disease

For Cetirizine Hydrochloride Chewable Tablets, 10 mg

adults and children 6	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A
years and over	5 mg product may be appropriate for less severe symptoms.
adults 65 years and	ask a doctor
over
children under 6 years of age	ask a doctor
consumers with liver	ask a doctor
or kidney disease

Other information

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, D&C YELLOW # 10, FD&C RED # 40, FD&C YELLOW # 6, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polacrilex resin, sodium starch glycolate, sucralose and tutti frutti flavor
QUESTIONS

Call 1-866-403-7592

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For 5 mg Allergy:

NDC: 40032-653-03

Children's

Cetirizine Hydrochloride Chewable Tablets

5 mg

ALLERGY

Antihistamine

Indoor & Outdoor Allergies

Tutti-frutti Flavor

6 yrs. & older

30 CHEWABLE TABLETS

Container Label

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Container Carton

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For 10 mg Allergy:

NDC: 40032-652-31

Children's

Cetirizine Hydrochloride Chewable Tablets

10 mg

ALLERGY

Antihistamine

Indoor & Outdoor Allergies

Tutti-frutti Flavor

6 yrs. & older

Blister Label

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Blister Carton

NDC: 40032-652-30

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INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, chewable

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 40032-653-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/08/2016
2	NDC: 40032-653-30	3 in 1 CARTON	03/08/2016
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 40032-653-03	1 in 1 CARTON	03/08/2016
3		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206793	03/08/2016

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, chewable

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 40032-652-30	3 in 1 CARTON	03/08/2016
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 40032-652-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/08/2016
3	NDC: 40032-652-03	1 in 1 CARTON	03/08/2016
3		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206793	03/08/2016

Labeler - Novel Laboratories, Inc. (793518643)

Registrant - Novel Laboratories, Inc. (793518643)

Name	Address	ID/FEI	Business Operations
Establishment
Novel Laboratories, Inc.		793518643	analysis(40032-653, 40032-652) , manufacture(40032-653, 40032-652)

Cetirizine Hydrochloride by