CETIRIZINE HYDROCHLORIDE
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cetirizine hydrochloride tablet
Rugby Laboratories, Inc.
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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.
liver or kidney disease. Your doctor should determine if you need a different dose.
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
an allergic reaction to this product occurs. Seek medical help right away.
• 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.
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Adults and children 6years andover | 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 65years andover | ask a doctor. |
Children under 4-6 years of age | ask a doctor |
Children under 4 years of age | ask a doctor |
Consumers with liver or kidney disease | ask a doctor |
lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.
CETIRIZINE HYDROCHLORIDE
cetirizine tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA078780 | 03/23/2012 |
Labeler - Rugby Laboratories, Inc. (109178264) |
Revised: 03/2012 Rugby Laboratories, Inc.