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Cetirizine Hydrochloride by Major Pharmaceuticals

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5852

Cetrizine HCL Tablet 10 mg

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.

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

Other information
  • store between 20° and 25°C (68° - 77°F)

Inactive ingredients

Lactose Monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol, and titanium dioxide.

Questions or comments?

To Report an Adverse Event call 1-800-616-2417

Distributed By

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150, USA

PRINCIPAL DISPLAY PANEL - 10 mg

MAJOR PHARMACEUTICALS. NDC 0904-5852-61

Cetirizine 10 mg

Cetirizine Hydrochloride Tablets

Antihistamine/Original Prescription Strength 

Indoor & Outdoor Allergies

24 hour

Relief of

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

Keep the Carton.  It contains important information.  See end panel for expiration date.

*This product is not manufactured or distrubuted by McNeil-PPC, Inc., distributor of Zyrtec®. Zyrtec® is a registered trademark of UCB Pharma, S.A.

All Day Allergy Carton

All Day Allergy 100 Ct Bottle Label

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5852(NDC:60505-2633)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
MAGNESIUM STEARATE 
HYPROMELLOSES 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 3350 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code10MG;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5852-4114 TABLET, FILM COATED (14 TABLET) in 1 BOTTLE
2NDC:0904-5852-4345 TABLET, FILM COATED (45 TABLET) in 1 BOTTLE
3NDC:0904-5852-4630 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE
4NDC:0904-5852-60100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE
5NDC:0904-5852-61100 TABLET, FILM COATED (100 TABLET) in 1 BLISTER PACK
6NDC:0904-5852-8990 TABLET, FILM COATED (90 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/27/2007
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
Legacy Pharmaceutical Packaging143213275RELABEL(0904-5852), REPACK(0904-5852)

Revised: 07/2012
 
Major Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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