Label: CETIRIZINE HYDROLORIDE ALLERGY- cetirizine hydroloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 57664-263-31, 57664-263-34 - Packager: Caraco Pharmaceutical Laboratories, Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 3, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- Purpose
- Uses
- Warnings
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- When using this product
- STOP USE
- If pregnant or breast-feeding:
- Keep out of reach of children.
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Directions
- use only with enclosed dosing cup
adults and children 6 years and over
1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over
1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age
½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (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
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Questions or comments?
call toll-free 1-800-818-4555 weekdays
Dosing Cup Included
Dosing cup should be washed and left to air dry after each use.
Do not use if carton is opened, or if seal on bottle is broken or missing.
Dist. by: Caraco Pharmaceutical Laboratories, Ltd.
Detroit, Michigan 48202
Mfg. by: SUN Pharmaceutical Industries, Inc.
Bryan, Ohio 43506
6028L01 Iss: 09/11 -
Principal Display Panel
NDC 57664-263-31
2 years & older
Children’s
Cetirizine
Hydrochloride
1mg / mL Oral Solution, USP
antihistamine
ALLERGY
Indoor and Outdoor Allergies
24 Hour Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Dosing Cup Included
Do not use if carton is opened, or if seal on bottle is broken or missing.
2 years and older
Grape Syrup
4 fl. oz. (120 mL)
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROLORIDE ALLERGY
cetirizine hydroloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57664-263 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) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM ACETATE (UNII: 4550K0SC9B) SUCROSE (UNII: C151H8M554) Product Characteristics Color YELLOW (Colorless to slightly yellow) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57664-263-31 120 mL in 1 BOTTLE 2 NDC:57664-263-34 470 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091327 12/01/2011 Labeler - Caraco Pharmaceutical Laboratories, Ltd (146974886) Registrant - Sun Pharmaceutical Industries Inc. (621283733) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Inc. 621283733 MANUFACTURE, ANALYSIS