Label: CETIRIZINE HYDROCHLORIDE solution
- NDC Code(s): 61037-480-22, 61037-480-23, 61037-480-24, 61037-480-26, view more
- Packager: BAJAJ MEDICAL, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 3, 2025
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONDrug Facts
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Active Ingredient (in each 5 mL teaspoonful)
Cetirizine hydrochloride, USP 5 mg
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Purpose
Antihistamine
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Uses
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
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WARNINGSWarnings - Severe Allergy Warning - Severe Allergy Warning: Get emergency help - immediately if you have hives along with any of the following symptoms: trouble swallowing - dizziness or loss ...
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Directions
use with a dosing cup - adults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls ...
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Other information
Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)
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Inactive ingredients
glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose
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Questions or comments?
call toll-free - 1-800-581-2528 weekdays
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PRINCIPAL DISPLAY PANEL:
4 fl. oz. (120 mL) - NDC 61037-480-22
NDC 61037-480-22 - Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP - 6 yrs. & older - Antihistamine - Grape Flavored - HIVES Relief - 24 hour Relief of ITCHING - Due to ...
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PRINCIPAL DISPLAY PANEL:
16 fl. oz. (480 mL) - NDC 61037-480-23
NDC 61037-480-23 - Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP - 6 yrs. & older - Antihistamine - Grape Flavored - HIVES Relief - 24 hour Relief of ITCHING - Due ...
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PRINCIPAL DISPLAY PANEL:
8 fl. oz. (240 mL) - NDC 61037-480-24
NDC 61037-480-24 - Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP - 6 yrs. & older - Antihistamine - Grape Flavored - HIVES Relief - 24 hour Relief of ITCHING - Due ...
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PRINCIPAL DISPLAY PANEL:
5 mL - NDC 61037-480-32
NDC 61037-480-32 - Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP - 6 yrs. & older - Antihistamine - Grape Flavored - HIVES Relief - 24 hour Relief of ITCHING - Due to ...
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INGREDIENTS AND APPEARANCEProduct Information