SPL UNCLASSIFIED SECTION.
Drug Facts.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each tablet). Fexofenadine HCl, USP 180 mg.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have kidney disease. Your doctor should determine if you need different dose.
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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.
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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, 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 toll-free weekdays 8:30 AM to PM EST at 1-800-818-4555.
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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. do not take more than directeddo not take at the same time as aluminum or magnesium antacidsdo not take with fruit juices (see Directions) do not take more than directed. do not take at the same time as aluminum or magnesium antacids. do not take with fruit juices (see Directions).
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL. PRINCIPAL DISPLAY PANEL.
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DOSAGE & ADMINISTRATION SECTION.
Directions. adults and children 12 years of age and overtake one 180 mg tablet with water once day; do not take more than tablet in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask doctorconsumers with kidney diseaseask doctor.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny noseitchy, watery eyessneezingitching of the nose or throat. runny nose. itchy, watery eyes. sneezing. itching of the nose or throat.
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STORAGE AND HANDLING SECTION.
Other information. safety sealed: do not use if carton is opened or if inner safety seal is torn or missingstore between 20 to 25C (68 to 77F)protect from excessive moisture. safety sealed: do not use if carton is opened or if inner safety seal is torn or missing. store between 20 to 25C (68 to 77F). protect from excessive moisture.
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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 . Ask doctor before use if you have kidney disease. Your doctor should determine if you need different dose. When using this product. do not take more than directeddo not take at the same time as aluminum or magnesium antacidsdo not take with fruit juices (see Directions) do not take more than directed. do not take at the same time as aluminum or magnesium antacids. do not take with fruit juices (see Directions) . Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. . If pregnant or breast-feeding, 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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