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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  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • Active Ingredient (in each 5 mL teaspoonful)
    Cetirizine hydrochloride, USP 5 mg
  • Purpose
    Antihistamine
  • Uses
    reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
  • WARNINGS
    Warnings - 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 ...
  • 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 ...
  • Other information
    Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)
  • Inactive ingredients
    glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose
  • Questions or comments?
    call toll-free - 1-800-581-2528 weekdays
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • INGREDIENTS AND APPEARANCE
    Product Information