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 Major Pharmaceuticals. 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.
Other
Drug Facts
Active Ingredient (In Each Tablet)
Cetirizine HCl 10 mg
Purpose
Antihistamine
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
Otc - 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.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - 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 drinks• alcohol, sedatives, and tranquilizers may increase drowsiness• be careful when driving a motor vehicle or operating machinery
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Warnings
If pregnant or breast-feeding:
• if breast-feeding; not recommended• if pregnant; ask a health professional before use
Otc - 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.
Directions
adults and children 6 years and over | Take 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 |
Other Information
• store between 20° and 25°C (68° - 77°F)
Inactive Ingredients
Lactose Monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol, and titanium dioxide.
Questions Or Comments?
call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time
Manufactured by:
Apotex In c.
Toronto, Ontario
Canada M9L 1T9
Manufactured for:
Apotex Corp.
Weston, Florida
33326
Distributed By:
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150
Principal Display Panel
Cetirizine 10 mg
Cetirizine Hydrochloride Tablets
Antihistamine/Original Prescription Strength
Indoor & Outdoor Allergies
24 hour
Relief of
Cetirizine HCl Tablets, 10 mg
14 Tablets
Cetirizine HCl Tablets, 10 mg
30 Tablets
Cetirizine HCl Tablets, 10 mg
45 Tablets
Cetirizine HCl Tablets, 10 mg
90 Tablets
Cetirizine HCl Tablets, 10 mg
100 Tablets
Cetirizine HCl Tablets, 10 mg
100 Tablets
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