CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE RISING PHARMA HOLDINGS, INC. FDA Approved Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
FunFoxMeds bottle
Route
ORAL
Applications
ANDA091327

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each 5 mL teaspoonful) Cetirizine hydrochloride USP 5 mg
Inactive Ingredients
Inactive ingredients glacial acetic acid glycerin grape flavor methylparaben propylene glycol propylparaben purified water sodium acetate and sucrose
Strengths
5 ml 5 mg
Quantities
120 ml 240 ml
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Itchy Watery Eyes Itching Of The Nose Or Throat

Identifiers & Packaging

Container Type BOTTLE
UPC
0357237357248
UNII
64O047KTOA
Packaging

PRINCIPAL DISPLAY PANEL: 4 fl. oz. (120 mL) - NDC 57237-357-12 NDC 57237-357-12 Children’s 2 yrs. & older Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL Antihistamine Grape Flavored ALLERGY Indoor and Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 4 fl. oz. (120 mL) Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 09/2025 cetirizine-hcl-os-120mL-1 cetirizine-hcl-os-120mL-2 cetirizine-hcl-os-120mL-3; PRINCIPAL DISPLAY PANEL: 8 fl. oz. (240 mL) - NDC 57237-357-24 NDC 57237-357-24 Children’s 2 yrs. & older Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL Antihistamine Grape Flavored ALLERGY Indoor and Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 8 fl. oz. (240 mL) Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 09/2025 cetirizine-hcl-os-240mL-1 cetirizine-hcl-os-240mL-2 cetirizine-hcl-os-240mL-3

Package Descriptions
  • PRINCIPAL DISPLAY PANEL: 4 fl. oz. (120 mL) - NDC 57237-357-12 NDC 57237-357-12 Children’s 2 yrs. & older Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL Antihistamine Grape Flavored ALLERGY Indoor and Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 4 fl. oz. (120 mL) Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 09/2025 cetirizine-hcl-os-120mL-1 cetirizine-hcl-os-120mL-2 cetirizine-hcl-os-120mL-3
  • PRINCIPAL DISPLAY PANEL: 8 fl. oz. (240 mL) - NDC 57237-357-24 NDC 57237-357-24 Children’s 2 yrs. & older Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL Antihistamine Grape Flavored ALLERGY Indoor and Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 8 fl. oz. (240 mL) Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 09/2025 cetirizine-hcl-os-240mL-1 cetirizine-hcl-os-240mL-2 cetirizine-hcl-os-240mL-3

Overview

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage & Administration

Directions use with a dosing cup find right dose on chart below mL = milliliter 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

Warnings & Precautions
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. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. 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. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away toll-free number 1-800-222-1222.
Purpose

Purpose Antihistamine

Do Not Use

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.

When Using

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 & Ask a Doctor

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away toll-free number 1-800-222-1222.

Storage & Handling

Other information Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)

Questions

Questions or comments? call toll-free 1-844-474-7464


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