CETRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution 
Major Pharmaceuticals

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Cetirizine Hydrochloride Oral Solution 1 mg/mL

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or 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
  • find right dose on chart below
  • mL = milliliter
  • tsp = teaspoonful
adults and children 6 years and over1 tsp (5 mL) or 2 tsp (10 mL) once daily depending upon severity of symptoms; do not take more than 2 tsp (10 mL) in 24 hours.
adults 65 years and over1 tsp (5 mL) once daily; do not take more than 1 tsp (5 mL) in 24 hours.
children 2 to under 6 years of age1/2 tsp (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 tsp (5 mL) once daily or 1/2 tsp (2.5 mL) every 12 hours. Do not give more than 1 tsp (5 mL) 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

17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 0904-6372-20

MAJOR ®

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
24 Hour

(118 mL)
2 yrs. & older
Dosing Cup Included

Dye-Free

Grape
Flavored
Syrup

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
CETRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6372
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
GRAPE (UNII: 6X543N684K)  
ACETIC ACID (UNII: Q40Q9N063P)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (Colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6372-201 in 1 CARTON02/24/201407/31/2019
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09047402/24/201407/31/2019
Labeler - Major Pharmaceuticals (191427277)

Revised: 9/2019
 
Major Pharmaceuticals