Your browser does not support JavaScript! ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]
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RxNorm Names

ZYRTEC (cetirizine hydrochloride) tablet, film coated
[McNeil Consumer Healthcare Div McNeil-PPC, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

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 overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if imprinted foil inner seal on bottle is broken or missing

Inactive ingredients

carnauba wax, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Questions?

call 1-800-343-7805

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-729-45

ZYRTEC®ALLERGY

Cetirizine HCl/
antihistamine
10 mg tablets

Indoor & Outdoor Allergies

24
hour

Relief of

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

45
Tablets
10 mg each

Principal Display Panel
ZYRTEC 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-729
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride10 mg
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize9mm
FlavorImprint Code ZYRTEC;10;MG
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-729-011 in 1 POUCH
2NDC:50580-729-021 in 1 POUCH
3NDC:50580-729-0350 in 1 CARTON
3NDC:50580-729-021 in 1 POUCH
4NDC:50580-729-055 in 1 PACKAGE
41 in 1 BLISTER PACK
5NDC:50580-729-133 in 1 CARTON
51 in 1 BLISTER PACK
6NDC:50580-729-141 in 1 PACKAGE
614 in 1 BOTTLE, PLASTIC
7NDC:50580-729-301 in 1 PACKAGE
730 in 1 BOTTLE, PLASTIC
8NDC:50580-729-451 in 1 PACKAGE
845 in 1 BOTTLE, PLASTIC
9NDC:50580-729-501 in 1 PACKAGE
950 in 1 BOTTLE, PLASTIC
10NDC:50580-729-512 in 1 PACKAGE
1050 in 1 BOTTLE, PLASTIC
11NDC:50580-729-701 in 1 PACKAGE
1170 in 1 BOTTLE, PLASTIC
12NDC:50580-729-901 in 1 PACKAGE
1290 in 1 BOTTLE, PLASTIC
13NDC:50580-729-7575 in 1 PACKAGE, COMBINATION
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01983501/01/2008
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 12/2009
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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