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Cetirizine Hydrochloride by Novel Laboratories, Inc.

Dosage form: tablet, chewable
Ingredients: CETIRIZINE HYDROCHLORIDE 5mgCETIRIZINE HYDROCHLORIDE 10mg
Labeler: Novel Laboratories, Inc.
NDC Code: 40032-653

Cetirizine Hydrochloride Chewable Tablets

Active Ingredient in each chewable tablet

For 5 mg:

Cetirizine hydrochloride 5 mg

For 10 mg:

Cetirizine hydrochloride 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 reactions 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 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 the reach of children

In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Directions
  • may be taken with or without water

For Cetirizine Hydrochloride Chewable Tablets, 5 mg

adults and children 6 years
1 to 2 tablets once daily depending upon severity of symptoms; do not take
and over
more than 2 tablets in 24 hours.
adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in 24 hours


children under 6 years of
ask a doctor
age

consumers with liver or
ask a doctor
kidney disease

For Cetirizine Hydrochloride Chewable Tablets, 10 mg

adults and children 6
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A
years and over
5 mg product may be appropriate for less severe symptoms.
adults 65 years and
ask a doctor
over

children under 6 years of age
ask a doctor
consumers with liver
ask a doctor
or kidney disease

Other information

  • store between 20° to 25°C (68° to 77°F)
  • Do not use if individual blister unit is open or torn

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, D&C YELLOW # 10, FD&C RED # 40, FD&C YELLOW # 6, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polacrilex resin, sodium starch glycolate, sucralose and tutti frutti flavor

QUESTIONS

Call 1-866-403-7592

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For 5 mg Allergy:

NDC 40032-653-03

Children's

Cetirizine Hydrochloride Chewable Tablets

5 mg

ALLERGY

Antihistamine

Indoor & Outdoor Allergies

Tutti-frutti Flavor

6 yrs. & older

30 CHEWABLE TABLETS

Container Label

Container Carton

For 10 mg Allergy:

NDC 40032-652-31

Children's

Cetirizine Hydrochloride Chewable Tablets

10 mg

ALLERGY

Antihistamine

Indoor & Outdoor Allergies

Tutti-frutti Flavor

6 yrs. & older

Blister Label

Blister Carton

NDC 40032-652-30

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40032-653
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 
POLACRILIN 
ACESULFAME POTASSIUM 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
SILICON DIOXIDE 
SUCRALOSE 
MAGNESIUM STEARATE 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorTUTTI FRUTTIImprint Coden;5
Contains    
Packaging
#Item CodePackage Description
1NDC:40032-653-101000 TABLET, CHEWABLE in 1 BOTTLE
2NDC:40032-653-303 BLISTER PACK in 1 CARTON
210 TABLET, CHEWABLE in 1 BLISTER PACK
3NDC:40032-653-031 BOTTLE in 1 CARTON
330 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20679303/08/2016
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40032-652
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 
POLACRILIN 
ACESULFAME POTASSIUM 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
SILICON DIOXIDE 
SUCRALOSE 
MAGNESIUM STEARATE 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize10mm
FlavorTUTTI FRUTTIImprint Coden;10
Contains    
Packaging
#Item CodePackage Description
1NDC:40032-652-303 BLISTER PACK in 1 CARTON
110 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:40032-652-101000 TABLET, CHEWABLE in 1 BOTTLE
3NDC:40032-652-031 BOTTLE in 1 CARTON
330 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20679303/08/2016
Labeler - Novel Laboratories, Inc. (793518643)
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
NameAddressID/FEIOperations
Novel Laboratories, Inc.793518643analysis(40032-653, 40032-652), manufacture(40032-653, 40032-652)

 
Novel Laboratories, Inc.

← See all Cetirizine Hydrochloride brands

Medically reviewed on Mar 22, 2018

Further information

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

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