Cetirizine Hydrochloride Tablets
Drug Facts
Cetirizine Hydrochloride
FDA Label NDC 71309-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safrel Pharmaceuticals, Llc for the product Cetirizine Hydrochloride (NDC 71309-005). 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 cetirizine hydrochloride tablets, active ingredient, purpose, use(s), do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Cetirizine HCl 10 mg
Purpose
Antihistamine
Use(S)
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
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
liver or kidney disease. Your doctor should determine if you need a different dose.
Ask A Doctor Or Pharmacist Before Use If
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 Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy/Breastfeeding
- 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
| adults and children 6 years and over | one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. |
| adults 65 years and over | ask a doctor |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Storage
- store between 20° to 25°C (68° to 77°F)
Other Information
◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
* Please review the disclaimer below.
