Other
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Cetirizine Hydrochloride (NDC 57237-357). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml teaspoonful), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Cetirizine hydrochloride, USP 5 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding:
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.
| 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 |
Store between 20 to 25°C (68 to 77°F) or store refrigerated, 2 to 8°C (36 to 46°F)
glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose
call toll-free 1-844-474-7464
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
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
* Please review the disclaimer below.