CETRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution

Cetrizine Hydrochloride by

Drug Labeling and Warnings

Cetrizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by APOZEAL PHARMACEUTICALS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 5 mL teaspoonful)       Purpose

Cetirizine HCl 5 mg----------------------------------Antihistamine

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or 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. (1-800-222-1222)

Directions

• use only with enclosed 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 2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 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).Excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
• Do not use if foil seal over mouth of the bottle is torn, broken or missing.
• Gluten Free
• Dosing cup should be washed and left to air dry after each use.

Inactive ingredients

glacial acetic acid, glycerine, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions or comments?

1-833-688-7848

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Distributed by:
Apozeal Pharmaceuticals Inc.
Hartel St, Levittown PA 19057

PRINCIPAL DISPLAY PANEL 

NDC: 83745-188-12

Cetirizine Hydrochloride

Oral Solution 1 mg/mL
Antihistamine

INDOOR & OUTDOOR
ALLERGIES

(120 mL)

Grape Flavored Syrup

NDC 83745-188-24

Cetirizine Hydrochloride

Oral Solution 1 mg/mL
Antihistamine

INDOOR & OUTDOOR
ALLERGIES

(240 mL)

Grape Flavored Syrup

INGREDIENTS AND APPEARANCE

CETRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83745-188
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
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM ACETATE (UNII: 4550K0SC9B)
GRAPE (UNII: 6X543N684K)
ACETIC ACID (UNII: Q40Q9N063P)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW (Colorless to slightly yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83745-188-04	1 in 1 CARTON	12/22/2025
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 83745-188-08	1 in 1 CARTON	04/16/2026
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 83745-188-16	1 in 1 CARTON	04/16/2026
3		473 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 83745-188-12	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2026
5	NDC: 83745-188-24	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2026
6	NDC: 83745-188-48	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090474	01/01/2025

Labeler - APOZEAL PHARMACEUTICALS INC (119101193)

Registrant - APOZEAL PHARMACEUTICALS INC (119101193)

Establishment
Name	Address	ID/FEI	Business Operations
APOZEAL PHARMACEUTICALS INC		119101193	MANUFACTURE(83745-188) , ANALYSIS(83745-188) , pack(83745-188)