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Zyrtec Allergy by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Medically reviewed on September 24, 2016

Dosage form: tablet, film coated
Ingredients: Cetirizine Hydrochloride 10mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-726

Zyrtec® Allergy

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 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 50580-726-36

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

30 Tablets
10 mg each

(Actual Size)

ZYRTEC ALLERGY 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-726
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
Silicon Dioxide 
Croscarmellose Sodium 
Hypromellose, Unspecified 
Lactose Monohydrate 
Magnesium Stearate 
Microcrystalline Cellulose 
Polyethylene Glycol, Unspecified 
Titanium Dioxide 
Product Characteristics
ColorWHITEScore2 pieces
ShapeRECTANGLE (rounded-off rectangular biconvex tablet) Size9mm
FlavorImprint CodeZYRTEC;10;MG
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-726-0350 BLISTER PACK in 1 CARTON
11 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:50580-726-133 BLISTER PACK in 1 CARTON
21 TABLET, FILM COATED in 1 BLISTER PACK
3NDC:50580-726-305 BLISTER PACK in 1 PACKAGE
31 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:50580-726-3214 BLISTER PACK in 1 PACKAGE
41 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:50580-726-361 BOTTLE, PLASTIC in 1 PACKAGE
530 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
6NDC:50580-726-501 BOTTLE, PLASTIC in 1 PACKAGE
650 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
7NDC:50580-726-512 BOTTLE, PLASTIC in 1 PACKAGE
750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
8NDC:50580-726-381 BOTTLE, PLASTIC in 1 PACKAGE
845 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
9NDC:50580-726-701 BOTTLE, PLASTIC in 1 PACKAGE
970 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
10NDC:50580-726-902 BOTTLE, PLASTIC in 1 PACKAGE
1045 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
11NDC:50580-726-6675 TABLET, FILM COATED in 1 PACKAGE, COMBINATION
12NDC:50580-726-401 BOTTLE, PLASTIC in 1 PACKAGE
1240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01983501/01/2008
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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