Active Ingredient
(in each tablet)
Cetirizine HCl 5 mg
Cetirizine Hydrochloride Tablet
FDA Label NDC 65162-045
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amneal Pharmaceuticals Llc for the product Cetirizine Hydrochloride (NDC 65162-045). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, indications and usage, warnings, ask doctor, ask doctor/pharmacist, stop use, pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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