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

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

WARNINGS

Warnings

Severe Allergy Warning

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

• trouble swallowing
• dizziness or loss of consciousness
• swelling of tongue
• swelling in or around mouth
• trouble speaking
• drooling
• wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

Do not use

■ to prevent hives from any known cause such as:

• foods
• insect stings
• medicines
• latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

■ 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.
• hives that are an unusual color, look bruised or blistered
• hives that do not itch

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.
• symptoms do not improve after 3 days of treatment
• the hives have lasted more than 6 weeks

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

• 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 under 6 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:

61037-480-22

NDC: 61037-480-22

Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP

6 yrs. & older

Antihistamine
Grape Flavored

HIVES Relief

24 hour Relief of ITCHING
Due to Hives

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: 06/2025

PRINCIPAL DISPLAY PANEL: 16 fl. oz. (480 mL) - NDC:

61037-480-23

NDC: 61037-480-23

Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP

6 yrs. & older

Antihistamine
Grape Flavored

HIVES Relief

24 hour Relief of ITCHING
Due to Hives

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: 06/2025

PRINCIPAL DISPLAY PANEL: 8 fl. oz. (240 mL) - NDC:

61037-480-24

NDC: 61037-480-24

Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP

6 yrs. & older

Antihistamine
Grape Flavored

HIVES Relief

24 hour Relief of ITCHING
Due to Hives

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:

61037-480-32

NDC: 61037-480-32

Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP

6 yrs. & older

Antihistamine
Grape Flavored

HIVES Relief

24 hour Relief of ITCHING
Due to Hives

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: 61037-480-22	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/08/2025
2	NDC: 61037-480-23	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/08/2025
3	NDC: 61037-480-24	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/08/2025
4	NDC: 61037-480-26	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product	05/08/2025
5	NDC: 61037-480-32	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)