NDC Code(s) : 59779-837-26, 59779-837-34
Packager : CVS Pharmacy

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

allergy relief Cetirizine HCl SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-837
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE(UNII: 64O047KTOA)
(CETIRIZINE - UNII:YO7261ME24) 		CETIRIZINE HYDROCHLORIDE5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SORBITOL SOLUTION(UNII: 8KW3E207O2)
SUCRALOSE(UNII: 96K6UQ3ZD4)
Product Characteristics
Color YELLOW (Clear to light yellow) Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59779-837-261 in 1 CARTON 09/11/2015
1120 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:59779-837-341 in 1 CARTON 09/11/2015
2240 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204226 09/11/2015

LABELER - CVS Pharmacy(062312574)

PRINCIPAL DISPLAY PANEL

CVS Health®

Compare to the active ingredient in Children’s Zyrtec®

Indoor & Outdoor Allergies

Children’s Allergy Relief

24 HOUR

CETIRIZINE HYDROCHLORIDE ORAL SOLUTION 1 mg/mL

Antihistamine

24 hour relief of:

Sneezing; Runny nose; Itchy, watery eyes; Itchy throat or nose

2 years & older

DYE FREE

Bubble Gum Flavor

Dosage Cup Included

Free of alcohol, sugar & gluten

8 FL OZ (240 mL)

allergy-relief