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Cetrizine Hydrochloride

Dosage form: solution
Ingredients: CETIRIZINE HYDROCHLORIDE 1mg in 1mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-6372

Cetrizine Hydrochloride Oral Solution 1mg/mL

Drug Facts

Active ingredient (in each 5mL teaspoonful)

Cetirizine HCl 5mg

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
  • use only with enclosed dosing cup
adults and children 6 years and over1 tsp (teaspoonful) (5mL) or 2 tsp (teaspoonfuls) (10mL) once daily depending upon severity of symptoms; do not take more than 2tsp (teaspoonfuls) (10mL) in 24 hours
adults 65 years and over1 tsp (teaspoonful) (5mL) once daily; do not take more than 1 tsp (teaspoonful) (5mL) in 24 hours
children 2 to under 6 years of age½ tsp (teaspoonful) (2.5mL) once daily. If needed, dose can be increased to a maximum of 1 tsp (teaspoonful) (5mL) once daily or ½ tsp(teaspoonful) (2.5mL) every 12 hours. Do not give more than 1 tsp (teaspoonful) (5mL) in 24 hours
children under 2 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 foil seal over mouth of the bottle is torn, broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

glacial acetic acid, glycerine, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions or comments?

1-800-616-2471

Distributed by
MAJOR® PHARMACEUTICALS

31778 Enterprise Drive
Livonia, MI 48150 USA

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

MAJOR®
NDC 0904-6372-20

COMPARE TO the active ingredient
of CHILDREN'S ZYRTEC®*

Children's
ALL DAY
Allergy

Cetirizine Hydrochloride
Oral Solution 1 mg/mL
Antihistamine

INDOOR & OUTDOOR
ALLERGIES

24 HOUR RELIEF OF:
Runny Nose / Itchy, Watery Eyes
Itchy Throat or Nose / Sneezing

4 FL OZ
(118 mL)

24 Hour
2 yrs. & older
Dosing Cup Included

Dye-Free

Grape
Flavored
Syrup

CETRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6372
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
PROPYLPARABEN 
GLYCERIN 
PROPYLENE GLYCOL 
SODIUM ACETATE 
GRAPE 
ACETIC ACID 
SUCROSE 
WATER 
Product Characteristics
ColorYELLOW (Colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6372-201 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09047402/24/2014
Labeler - Major Pharmaceuticals (191427277)
Registrant - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546MANUFACTURE(0904-6372), ANALYSIS(0904-6372), PACK(0904-6372), LABEL(0904-6372)

Revised: 03/2014
 
Major Pharmaceuticals

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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