Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE STARCH, CORN MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYDEXTROSE POLYETHYLENE GLYCOL 3350 TITANIUM DIOXIDE pillow-shaped 10MG;APO
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel MAJOR® NDC 0904-5852-60 Compare to active ingredient In Zyrtec® Original Prescription Strength ALL DAY ALLERGY Cetirizine HCl Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 TABLETS 10 mg EACH representative label
- Principal Display Panel MAJOR® NDC 0904-5852-60 Compare to active ingredient In Zyrtec® Original Prescription Strength ALL DAY ALLERGY Cetirizine HCl Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 TABLETS 10 mg EACH representative label
Overview
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
Indications & Usage
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
Dosage & Administration
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
Warnings & Precautions
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 a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. 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 Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • 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) If pregnant or breast-feeding: • if breast-feeding; not recommended • if pregnant; ask a health professional before use
Purpose
Purpose Antihistamine
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.
When Using
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 & Ask a Doctor
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
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. (1-800-222-1222)
Storage & Handling
Other information • store between 20° and 25°C (68° - 77°F) • do not use if seal under bottle cap is broken or missing • meets USP Dissolution Test 3
Questions
Questions or comments? call 1-800-706-5575 , weekdays, 8:30am - 5:00pm Eastern Standard Time *This product is not manufactured or distributed by McNeil-PPC, Inc. owner of the registered trademark Zyrtec® 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
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