Zyrtec

Name: Zyrtec

How supplied

NDC 50580-779-12

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 or comments ?

call 1-800-343-7805

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Revised: Dec 2015

Overdose

No information provided.

What should i discuss with my healthcare provider before taking cetirizine?

You should not use this medication if you are allergic to cetirizine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have any medical conditions.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Cetirizine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may need to take a lower than normal dose. Follow your doctor's instructions.

Introduction

Second generation antihistamine; piperazine-derivative, carboxylic acid metabolite of hydroxyzine.1 2 3 11 12 20

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cetirizine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, liquid-filled

10 mg*

Cetirizine Hydrochloride Capsules

ZyrTEC Liquid Gels

McNeil

Solution

5 mg/5 mL*

Cetirizine Hydrochloride Oral Solution

Children’s ZyrTEC Allergy Syrup

McNeil

Children’s Zyrtec Perfect Measure

McNeil

Tablets

5 mg*

Cetirizine Hydrochloride Tablets

10 mg*

Cetirizine Hydrochloride Tablets

Tablets, chewable

5 mg*

Cetirizine Hydrochloride Chewable Tablets

Children’s ZyrTEC Chewables

McNeil

10 mg*

Cetirizine Hydrochloride Chewable Tablets

Children’s ZyrTEC Chewables

McNeil

Tablets, film-coated

5 mg*

Cetirizine Hydrochloride Tablets

10 mg*

Cetirizine Hydrochloride Tablets

ZyrTEC

McNeil

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cetirizine Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, extended-release

5 mg with Pseudoephedrine Hydrochloride 120 mg*

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Tablets

ZyrTEC-D

McNeil

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

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

Principal display panel

Original Prescription Strength

NDC 50580-726-36

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

30
Tablets
10 mg each

Zyrtec 
cetirizine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-726
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 10 mg
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
1 NDC:50580-726-03 50 BLISTER PACK (BLISTER) in 1 CARTON
1 1 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
2 NDC:50580-726-13 3 BLISTER PACK (BLISTER) in 1 CARTON
2 1 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
3 NDC:50580-726-30 5 BLISTER PACK (BLISTER) in 1 PACKAGE
3 1 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
4 NDC:50580-726-32 14 BLISTER PACK (BLISTER) in 1 PACKAGE
4 1 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
5 NDC:50580-726-36 1 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
5 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
6 NDC:50580-726-50 1 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
6 50 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
7 NDC:50580-726-51 2 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
7 50 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
8 NDC:50580-726-38 1 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
8 45 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
9 NDC:50580-726-70 1 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
9 70 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
10 NDC:50580-726-90 2 BOTTLE, PLASTIC (BOTTLE) in 1 PACKAGE
10 45 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
11 NDC:50580-726-66 75 TABLET, FILM COATED (TABLET) in 1 PACKAGE, COMBINATION
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019835 10/01/2008
Labeler - McNeil Consumer Healthcare Division of McNeil-PPC, Inc. (878046358)
Revised: 01/2010   McNeil Consumer Healthcare Division of McNeil-PPC, Inc.

For the Consumer

Applies to cetirizine: oral solution, oral tablets and chewable tablets

Side effects include:

Adults and children ≥12 years of age: Somnolence, fatigue, dry mouth. Insomnia reported with cetirizine (the active ingredient contained in Zyrtec) hydrochloride-pseudoephedrine hydrochloride fixed combination.

Children 2–11 years of age: Headache, pharyngitis, abdominal pain.

Children 6 months to 2 years of age: Irritability, fussiness, insomnia, fatigue, malaise.

How it works

Zyrtec is a brand (trade) name for cetirizine. Cetirizine is an antihistamine that works on histamine receptors to block the allergic response and allergy symptoms.

Bottom Line

Zyrtec effectively treats allergic type reactions and generally does not cause drowsiness.

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