DailyMed - CETIRIZINE HYDROCHLORIDE solution

NDC Code(s): 61037-480-02, 61037-480-03, 61037-480-04, 61037-480-06, view more
61037-480-12
Packager: BAJAJ MEDICAL, LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 3, 2025

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active Ingredient (in each 5 mL teaspoonful)
Cetirizine hydrochloride, USP 5 mg

Cetirizine hydrochloride, USP 5 mg
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Purpose
Antihistamine

Antihistamine
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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
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
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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 ...
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.

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Directions

use with a dosing cup - find right dose on chart below - mL = milliliter - adults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of ...

Other information
Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)

Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)
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Inactive ingredients
glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose

glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose
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Questions or comments?
call toll-free - 1-800-581-2528 weekdays

call toll-free 1-800-581-2528 weekdays
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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 ...

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

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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 ...

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

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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 ...

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

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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 ...

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

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INGREDIENTS AND APPEARANCE

Product Information

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

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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

	RxCUI	RxNorm NAME	RxTTY
1	1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN
2	1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD
3	1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY
4	1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY

Label: CETIRIZINE HYDROCHLORIDE solution

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	NDC
1	61037-480-02
2	61037-480-03
3	61037-480-04
4	61037-480-06
5	61037-480-12

Label: CETIRIZINE HYDROCHLORIDE solution

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Drug Label Info

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Drug Label Information

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Safety

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CETIRIZINE HYDROCHLORIDE solution

Number of versions: 1

CETIRIZINE HYDROCHLORIDE solution

CETIRIZINE HYDROCHLORIDE solution

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CETIRIZINE HYDROCHLORIDE solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.