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Cetirizine Hydrochloride by Major Pharmaceuticals

Dosage form: tablet, chewable
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5879

Drug Facts

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 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.

Directions
may be taken with or without water

 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

Other information
Store between 20 to 25 C (68 to 77 F)
See end flap for expiration date and lot number

Inactive ingredients

acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor

Questions? (800) 616-2471

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Zyrtec (R) Allergy.

50844

ORG060857802

Distributed by MAJOR (R) PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI 48150 USA    M-126

Rev 08/12

Re-order No. 255535

Product of India     

OTC - ACTIVE INGREDIENT SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

All Day Children's Allergy - Cetirizine HCl 10mg Chewable

NDC 0904-5879-12

Children's

Cetirizine HCl Chewable Tablets

10 mg

antihistamine

Tutti Frutti Flavored

30 Tablets

Do not use if individual blister unit is open or torn

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

6 yrs. and older 10 mg each

Principal Display Panel

NDC 0904-5879-12

Children's

Cetirizine HCl Chewable Tablets

10 mg

antihistamine

Tutti Frutti Flavored

30 Tablets

Do not use if individual blister unit is open or torn

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

6 yrs. and older 10 mg each

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5879(NDC:0781-5284)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
BENZYL ALCOHOL 
BETADEX 
SILICON DIOXIDE 
.ALPHA.-TOCOPHEROL, DL- 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
PROPYLENE GLYCOL 
TALC 
Product Characteristics
ColorYELLOW (peach, mottled) Scoreno score
ShapeROUNDSize9mm
FlavorImprint CodeSZ;106
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5879-1212 TABLET, CHEWABLE in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07869202/14/200808/17/2019
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
Major Pharmaceuticals191427277REPACK(0904-5879)

 
Major Pharmaceuticals

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Medically reviewed on Aug 8, 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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