INACTIVE INGREDIENT SECTION.
Inactive ingredients. Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin.
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DOSAGE & ADMINISTRATION SECTION.
Directions. adults and children years and over1 to tablets once daily depending upon severity of symptoms; do not take more than tablets in 24 hours.adults 65 years and over1 tablet once day; do not take more than tablet in 24 hourschildren under years of ageask doctorconsumers with liver or kidney diseaseask doctor.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:orunny noseosneezingoitchy, watery eyesoitching of the nose or throat. orunny nose. osneezing. oitchy, watery eyes. oitching of the nose or throat.
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OTC - ACTIVE INGREDIENT SECTION.
Active Ingredient (in each tablet). Cetirizine hydrochloride USP, mg.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have. liver or kidney disease. Your doctor should determine if you need different dose.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are. taking tranquilizers or sedatives.
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OTC - DO NOT USE SECTION.
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.
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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.
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OTC - PREGNANCY OR BREAST FEEDING SECTION.
If pregnant or breast-feeding:. oif breast-feeding: not recommendedoif pregnant: ask health professional before use.. oif breast-feeding: not recommended. oif pregnant: ask health professional before use.
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OTC - PURPOSE SECTION.
Purpose. Antihistamine.
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OTC - QUESTIONS SECTION.
Questions. Call 1-877-446-3679 (1-877-4-INFO-RX) Manufactured for:Mylan Pharmaceuticals Inc.Morgantown, WV 26505.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. an allergic reaction to this product occurs. Seek medical help right away.
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OTC - WHEN USING SECTION.
When using this product. odrowsiness may occuroavoid alcoholic drinksoalcohol, sedatives, and tranquilizers may increase drowsinessobe careful when driving motor vehicle or operating machinery. odrowsiness may occur. oavoid alcoholic drinks. oalcohol, sedatives, and tranquilizers may increase drowsiness. obe careful when driving motor vehicle or operating machinery.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL 5 mg AllergyNDC 0378-3635-01Cetirizine HClTablets, USPAllergy5 mgAntihistamineIndoor Outdoor Allergies24 Hour Relief oforunny noseosneezingoitchy, watery eyesoitching of the nose or throatRMX-AR3635A 100 TabletsTamper Evident: do not use if foil seal under cap is missing, open or broken.. orunny nose. osneezing. oitchy, watery eyes. oitching of the nose or throat. Cetirizine Hydrochloride Tablets mg Front Layer Bottle Label. Cetirizine Hydrochloride Tablets mg Back of Front Layer Bottle Label. Cetirizine Hydrochloride Tablets mg Base Layer Bottle Label.
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SPL UNCLASSIFIED SECTION.
Other information. ostore between 20 to 25C (68 to 77F). ostore between 20 to 25C (68 to 77F).
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WARNINGS SECTION.
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 doctor before use if you have. liver or kidney disease. Your doctor should determine if you need different dose.. Ask doctor or pharmacist before use if you are. taking tranquilizers or sedatives.. When using this product. odrowsiness may occuroavoid alcoholic drinksoalcohol, sedatives, and tranquilizers may increase drowsinessobe careful when driving motor vehicle or operating machinery. odrowsiness may occur. oavoid alcoholic drinks. oalcohol, sedatives, and tranquilizers may increase drowsiness. obe careful when driving motor vehicle or operating machinery. Stop use and ask doctor if. an allergic reaction to this product occurs. Seek medical help right away.. If pregnant or breast-feeding:. oif breast-feeding: not recommendedoif pregnant: ask health professional before use.. oif breast-feeding: not recommended. oif 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.
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