Label: CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE- cetirizine hydrochloride solution
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NDC Code(s):
51672-2102-1,
51672-2102-2,
51672-2102-4,
51672-2102-7, view more51672-2102-8
- 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 April 16, 2021
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 older 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 51672-2102-8
Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mLALLERGY
AntihistamineIndoor & Outdoor Allergies
SUGAR FREE
24
Hour
Relief of:- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
2 Yrs. & older
Grape Flavor
Dosing Cup Included
4 FL OZ
(120 mL) -
INGREDIENTS AND APPEARANCE
CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE
cetirizine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2102 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) methylparaben (UNII: A2I8C7HI9T) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) sodium acetate anhydrous (UNII: NVG71ZZ7P0) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE, BANANA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2102-4 1 in 1 CARTON 09/08/2011 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51672-2102-8 1 in 1 CARTON 09/08/2011 2 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:51672-2102-1 1 in 1 CARTON 09/08/2011 3 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:51672-2102-2 2 in 1 CARTON 09/08/2011 4 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:51672-2102-7 2 in 1 CARTON 09/08/2011 5 240 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 ANDA090182 09/08/2011 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries, Ltd. 600072078 MANUFACTURE(51672-2102) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2102)