DOSAGE & ADMINISTRATION SECTION.
Directions. adults 65 years of age and older ask doctor adults and children 12-64 years of age take tablet (5 mg) once daily in the eveningdo not take more than tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take 1/2 tablet (2.5 mg) once daily in the eveningdo not take more than 1/2 tablet (2.5 mg) in 24 hours children under years of age do not use consumers with kidney disease do not use. ask doctor. take tablet (5 mg) once daily in the evening. do not take more than tablet (5 mg) in 24 hours. 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms. take 1/2 tablet (2.5 mg) once daily in the evening. do not take more than 1/2 tablet (2.5 mg) in 24 hours. do not use. do not use.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms due to hay fever or other respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each tablet). Levocetirizine dihydrochloride USP, mg.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have. ever had trouble urinating or emptying your bladder. ever had trouble urinating or emptying your bladder.
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OTC - DO NOT USE SECTION.
Do not use. if you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine. if you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).
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OTC - PREGNANCY OR BREAST FEEDING SECTION.
If pregnant or breast-feeding:. if breast-feding: not recommendedif pregnant: ask health professional before use. if breast-feding: not recommended. if pregnant: ask health professional before use.
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OTC - PURPOSE SECTION.
Purpose. Antihistamine.
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OTC - QUESTIONS SECTION.
Questions or comments. Call 1-888-375-3784.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. you have trouble urinating or emptying your bladderan allergic reaction to this product occurs. Seek medical help right away. you have trouble urinating or emptying your bladder. an allergic reaction to this product occurs. Seek medical help right away.
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OTC - WHEN USING SECTION.
When using this product. drowsiness may occur avoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machinery drowsiness may occur. avoid alcoholic drinks. alcohol, sedatives, and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Carton Label. Rugby NDC 0536-1144-92Compare to Xyzal(R)Allergy 24HRactive ingredient Original Prescription Strength Levocetirizine Dihydrochloride Tablets USP, mg Antihistamine ALLERGY 24 HOUR Relief of:Sneezing Runny NoseItchy Nose or Throat Itchy, Watery Eyes 35 TABLETS. Sneezing Runny Nose. Itchy Nose or Throat Itchy, Watery Eyes.
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SPL UNCLASSIFIED SECTION.
carton. bottle. Blister Carton.
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WARNINGS SECTION.
Warnings. Do not use. if you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine. if you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine. Ask doctor before use if you have. ever had trouble urinating or emptying your bladder. ever had trouble urinating or emptying your bladder. When using this product. drowsiness may occur avoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machinery drowsiness may occur. avoid alcoholic drinks. alcohol, sedatives, and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery Stop use and ask doctor if. you have trouble urinating or emptying your bladderan allergic reaction to this product occurs. Seek medical help right away. you have trouble urinating or emptying your bladder. an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding:. if breast-feding: not recommendedif pregnant: ask health professional before use. if breast-feding: not recommended. if pregnant: ask health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).
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