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Drug Facts
Cetirizine Hydrochloride Solution
FDA Label NDC 61037-480
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bajaj Medical, Llc for the product Cetirizine Hydrochloride (NDC 61037-480). 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.
Label Section Quick Index
Active Ingredient (In Each 5 Ml Teaspoonful)
Cetirizine hydrochloride, USP 5 mg
Purpose
Antihistamine
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
Otc - 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.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Otc - 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
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Otc - 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.
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 |
Other Information
Store between 20 to 25°C (68 to 77°F) or store refrigerated, 2 to 8°C (36 to 46°F)
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 61037-480-02
NDC 61037-480-02
Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP
2 yrs. & older
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.
Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 01/2025
4oz1 (4oz 1)
4oz2 (4oz 2)
4oz3 (4oz 3)
4oz4 (4oz 4)
4oz5 (4oz 5)
4oz6 (4oz 6)
4oz7 (4oz 7)
Principal Display Panel: 16 Fl. Oz. (480 Ml) - Ndc 61037-480-03
NDC 61037-480-03
Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP
2 yrs. & older
Antihistamine
Grape Flavored
ALLERGY
Indoor and Outdoor Allergies
24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
16 fl. oz. (480 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.
Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 01/2025
16oz1 (16oz 1)
16oz2 (16oz 2)
16oz3 (16oz 3)
Principal Display Panel: 8 Fl. Oz. (240 Ml) - Ndc 61037-480-04
NDC 61037-480-04
Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP
2 yrs. & older
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.
Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 06/2025
8oz1 (8oz 1)
8oz2 (8oz 2)
8oz3 (8oz 3)
8oz4 (8oz 4)
8oz5 (8oz 5)
Principal Display Panel: 5 Ml - Ndc 61037-480-12
NDC 61037-480-12
Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP
2 yrs. & older
Antihistamine
Grape Flavored
ALLERGY
Indoor and Outdoor Allergies
24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
100 Unit Dose Cups
(Each Cup Delivers 5 mL)
Do not use if seal on cup is broken or missing.
Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 06/2025
5ml1 (5ml 1)
5ml2 (5ml 2)
5ml3 (5ml 3)
* Please review the disclaimer below.
