ZYRTEC- cetirizine hydrochloride capsule, liquid filled

ZYRTEC by

Drug Labeling and Warnings

ZYRTEC 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 capsule)

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 capsule once daily; do not take more than one 10 mg capsule 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 at 20°-25°C (68°-77°F)
• avoid high humidity and excessive heat above 40°C (104°F)
• protect from light
• do not use if foil inner seal printed with "SAFETY SEAL®" is broken or missing

Inactive ingredients

gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Questions?

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

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC: 50580-779-12

ZYRTEC®
ALLERGY

INDOOR + OUTDOOR
ALLERGIES

Cetirizine HCl/
antihistamine
10 mg capsules

LIQUID
GELS

24
HOUR
RELIEF OF

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

(Actual Size)

12
LIQUID GELS*
*LIQUID-FILLED CAPSULES
10 mg each

INGREDIENTS AND APPEARANCE

ZYRTEC 
cetirizine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-779
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
gelatin, unspecified (UNII: 2G86QN327L)
glycerin (UNII: PDC6A3C0OX)
mannitol (UNII: 3OWL53L36A)
polyethylene glycol 400 (UNII: B697894SGQ)
water (UNII: 059QF0KO0R)
sodium hydroxide (UNII: 55X04QC32I)
sorbitan (UNII: 6O92ICV9RU)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	YELLOW (Clear)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	Z10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-779-12	1 in 1 PACKAGE	02/08/2010
1		12 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50580-779-25	1 in 1 PACKAGE	02/08/2010
2		25 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 50580-779-40	1 in 1 PACKAGE	02/08/2010
3		40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 50580-779-65	65 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	02/08/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022429	02/08/2010

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