CHILDRENS ZYRTEC ALLERGY- cetirizine hydrochloride tablet, orally disintegrating

Childrens Zyrtec Allergy by

Drug Labeling and Warnings

Childrens 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

Tablet melts in mouth. Can 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). Avoid high humidity.
• do not use if blister unit is torn or broken

Inactive ingredients

amino methacrylate copolymer, anhydrous citric acid, colloidal silicon dioxide, crospovidone, flavors, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium starch glycolate, sucralose

Questions?

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

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC: 50580-782-12

Children's
ZyRTEC® ALLERGY

Cetirizine HCl orally disintegrating tablets
10 mg/antihistamine

Indoor + Outdoor
Allergies

Dissolve Tabs

6 yrs.
& older
10mg each

Citrus Flavor

24
hour

Relief of

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

Actual
Size

Melts In
Your Mouth

12 ORALLY DISINTEGRATING TABLETS

INGREDIENTS AND APPEARANCE

CHILDRENS ZYRTEC ALLERGY 
cetirizine hydrochloride tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-782
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
dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer (UNII: 905HNO1SIH)
anhydrous citric acid (UNII: XF417D3PSL)
silicon dioxide (UNII: ETJ7Z6XBU4)
crospovidone (15 MPA.S AT 5%) (UNII: 68401960MK)
hydroxypropyl cellulose (70000 WAMW) (UNII: 66O7AQV0RT)
magnesium stearate (UNII: 70097M6I30)
mannitol (UNII: 3OWL53L36A)
microcrystalline cellulose (UNII: OP1R32D61U)
sodium bicarbonate (UNII: 8MDF5V39QO)
sodium starch glycolate Type A Potato (UNII: 5856J3G2A2)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor	CITRUS	Imprint Code	Z10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-782-12	2 in 1 CARTON	01/20/2014
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50580-782-24	4 in 1 CARTON	01/20/2014
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 50580-782-01	2 in 1 PACKAGE	01/20/2014
3		4 in 1 CARTON
3		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
NDA	NDA022578	01/20/2014

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)