FDA Label for Cetirizine Hydrochloride
View Indications, Usage & Precautions
Cetirizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Amneal Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
(in each tablet)
Cetirizine HCl 5 mg
Purpose
Antihistamine
Indications And Usage
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
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 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/Pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
● drowsiness may occur
● avoid alcoholic drink
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy Or Breast Feeding
If pregnant or breast-feeding :
• if breast-feeding: not recommended
• if pregnant: ask a health professional
before use.
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.
Dosage And Administration
| Adults andchildren 6years andover | 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. |
| Adults 65years andover | 1 tablet once a day; do not take more than 1 tablet in 24 hours. |
| Childrenunder 6 yearsof age | ask a doctor |
| Consumerswith liver orkidneydisease | ask a doctor |
Other Information
Other information
• store between 20 to 25°C (68 to 77°F)
Inactive Ingredient
Inactive ingredients
lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.
Otc - Questions
Questions or Comments?
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