CETIRIZINE HYDROCHLORIDE tablet, chewable

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Novel Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient in each chewable tablet

Cetirizine Hydrochloride Chewable Tablets 10mg

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

• may be taken with or without water

• 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)
• Do not use if individual blister unit is open or torn

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

1-888-287-1915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-652
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	10mm
Flavor	TUTTI FRUTTI	Imprint Code	n;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-652-24	4 in 1 CARTON	03/08/2016
1	NDC: 49035-652-25	6 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Novel Laboratories, Inc. (793518643)

Establishment
Name	Address	ID/FEI	Business Operations
Novel Laboratories, Inc.		793518643	ANALYSIS(49035-652) , MANUFACTURE(49035-652) , PACK(49035-652)