Label: CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM- cetirizine hydrochloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 51672-2148-1, 51672-2148-8 - Packager: TARO PHARMACEUTICALS U.S.A., INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 26, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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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.
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.
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Directions
- use only with enclosed dosing cup
- find right dose on chart below
- mL = milliliter
adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Compare to the
active ingredient
in Children's Zyrtec®*NDC 51672-2148-8
Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL
ALLERGY
Antihistamine
Indoor & Outdoor AllergiesSUGAR FREE
24
Hour
Relief of:- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
2 Yrs. & older
Bubble Gum
FlavorDosing Cup Included
4 FL OZ
(120 mL) -
INGREDIENTS AND APPEARANCE
CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM
cetirizine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2148 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength acetic acid (UNII: Q40Q9N063P) glycerin (UNII: PDC6A3C0OX) propylene glycol (UNII: 6DC9Q167V3) sodium acetate anhydrous (UNII: NVG71ZZ7P0) sodium benzoate (UNII: OJ245FE5EU) sucralose (UNII: 96K6UQ3ZD4) water (UNII: 059QF0KO0R) Product Characteristics Color YELLOW (colorless to slightly yellow) Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2148-8 1 in 1 CARTON 06/29/2022 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51672-2148-1 1 in 1 CARTON 06/29/2022 2 240 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 ANDA201546 06/29/2022 Labeler - TARO PHARMACEUTICALS U.S.A., INC. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(51672-2148)