CETIRIZINE HYDROCHLORIDE
Summary of product characteristics
Dosage And Administration
Directions use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Indications And Usage
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
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. Side effects occur: You may report side effects to FDA at 1-800-FDA-1088. 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)
Effective Time
20230815
Version
100
Active Ingredient
Active ingredient (in each 5 mL) Cetirizine HCl 5 mg
Dosage And Administration Table
| adults and children 6 years and over | 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. |
| adults 65 years and over | 5 mL once daily; do not take more than 5 mL in 24 hours. |
| children 2 to under 6 years of age | 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Inactive Ingredient
Inactive ingredients Bubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose Grape Syrup: anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Purpose
Purpose Antihistamine
Spl Product Data Elements
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE ANHYDROUS CITRIC ACID PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE
Application Number
ANDA212266
Brand Name
CETIRIZINE HYDROCHLORIDE
Generic Name
CETIRIZINE HYDROCHLORIDE
Product Ndc
72162-2073
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
Cetirizine Hydrochloride Oral Solution Label
Spl Unclassified Section
Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 51001 & 51002 Rev. 10/18
Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask Doctor Or Pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
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.
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)
Questions
Questions? Call 1-888-344-9603 (toll-free)
Stop Use
Stop use and ask a doctor if: an allergic reaction to this product occurs. Seek medical help right away. Side effects occur: You may report side effects to FDA at 1-800-FDA-1088.
When Using
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
Pregnancy Or Breast Feeding
If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use.
How Supplied
HOW SUPPLIED NDC: 72162-2073-2: 118 mL in a BOTTLE Store between 20° to 25°C (68° to 77°F) Protect from light do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
Storage And Handling
Other Information store between 20° to 25°C (68° to 77°F) Protect from light do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing see bottom panel for lot number and expiration date
30 mins
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Disclaimer
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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.