ZYRTEC ALLERGY- cetirizine hydrochloride kit

Zyrtec Allergy by

Drug Labeling and Warnings

Zyrtec Allergy by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• store between 20° to 25°C (68° to 77°F)
• do not use if clamshell is opened or if foil inner seal imprinted with "ZYRTEC®" is broken or missing
• meets USP Dissolution Test 2

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC: 50580-752-01

ZYRTEC ®
ALLERGY

Cetirizine HCl tablets
10 mg /antihistamine

Indoor & Outdoor Allergies

24
hour

Relief of

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

(Actual Size)
120
Tablets
(contains one bottle of 50 Tablets
and one bottle of 70 Tablets)

Cut To Open

30045795

120 Tablets
10 mg each (contains one bottle of 50 Tablets and one bottle of 70 Tablets)

INGREDIENTS AND APPEARANCE

ZYRTEC ALLERGY 
cetirizine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-752

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-752-01	1 in 1 PACKAGE	06/15/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	50
Part 2	1 BOTTLE, PLASTIC	70

Part 1 of 2

ZYRTEC ALLERGY 
cetirizine hydrochloride tablet, film coated

Product Information
Item Code (Source)	NDC: 50580-726
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	2 pieces
Shape	RECTANGLE (rounded-off rectangular biconvex tablet)	Size	9mm
Flavor		Imprint Code	ZYRTEC;10;MG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-726-50	1 in 1 PACKAGE
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019835	01/26/2010

Part 2 of 2

ZYRTEC ALLERGY 
cetirizine hydrochloride tablet, film coated

Product Information
Item Code (Source)	NDC: 50580-726
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	2 pieces
Shape	RECTANGLE (rounded-off rectangular biconvex tablet)	Size	9mm
Flavor		Imprint Code	ZYRTEC;10;MG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-726-70	1 in 1 PACKAGE
1		70 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019835	01/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019835	06/15/2020

Labeler - Kenvue Brands LLC (118772437)