FDA Label for Cetirizine Hydrochloride

Other

Drug Facts

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

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

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

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