CETIRIZINE HYDROCHLORIDE solution

CETIRIZINE HYDROCHLORIDE by

Drug Labeling and Warnings

CETIRIZINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by BAJAJ MEDICAL, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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.

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 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:

61037-480-02

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

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

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

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

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61037-480
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
SODIUM ACETATE (UNII: 4550K0SC9B)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ACETIC ACID (UNII: Q40Q9N063P)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61037-480-02	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/08/2025
2	NDC: 61037-480-03	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/08/2025
3	NDC: 61037-480-04	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/08/2025
4	NDC: 61037-480-06	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product	05/08/2025
5	NDC: 61037-480-12	5 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	05/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091327	05/08/2025

Labeler - BAJAJ MEDICAL, LLC (078774921)

Registrant - BAJAJ MEDICAL, LLC (078774921)

Establishment
Name	Address	ID/FEI	Business Operations
BAJAJ MEDICAL, LLC		078774921	analysis(61037-480) , label(61037-480) , manufacture(61037-480) , pack(61037-480)