FDA Label for Cetrizine Hydrochloride

Other

Drug Facts

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

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

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.

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.

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. (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)
• 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

Principal Display Panel

NDC 83745-188-24

Cetirizine Hydrochloride

Oral Solution 1 mg/mL
Antihistamine

INDOOR & OUTDOOR
ALLERGIES

(240 mL)

Grape Flavored Syrup

image description - containerlabel240ml