FDA Label for Cetirizine Hydrochloride
View Indications, Usage & Precautions
- 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
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- STORAGE
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Cetirizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Granules India Ltd. 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.
Cetirizine Hydrochloride Tablets
Drug Facts
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.
Principal Display Panel
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