DOSAGE & ADMINISTRATION SECTION.
Directions. adults 65 years of age and older ask doctoradults and children 12-64 years of age 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 symptomschildren 6-11 years of age 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 hourschildren under years of age do not useconsumers with kidney disease do not use(Note: Age ranges are bolded in the draft container labeling for tablet bottle).
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. Colloidal anhydrous silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms due to hay fever or other respiratory allergies:runny nose sneezing itchy, watery eyes itching 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 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-feeding: not recommended if pregnant: ask health professional before use. if breast-feeding: 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 1-800- 633-1610.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. you have trouble urinating or emptying your bladder an 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 drinks alcohol, sedatives, and tranquilizers may increase drowsiness be 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.
PRINCIPAL DISPLAY PANEL. NDC 41167-3510-0XYZALAllergy 24HR5 mg10 Tablets. PRINCIPAL DISPLAY PANELNDC 41167-3510-0XYZALAllergy 24HR5 mg10 Tablets.
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SPL UNCLASSIFIED SECTION.
Xyzal Allergy 24HR TabletDrug Facts.
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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 drinks alcohol, sedatives, and tranquilizers may increase drowsiness be 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 bladder an 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-feeding: not recommended if pregnant: ask health professional before use. if breast-feeding: 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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