DOSAGE & ADMINISTRATION SECTION.
Directions. adults and children 12 years of age and over take one 180 mg tablet with water once day; do not take more than tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask doctor consumers with kidney disease ask doctor.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nose itchy, watery eyes sneezing itching of the nose or throat. runny nose itchy, watery eyes sneezing itching of the nose or throat.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each film-coated tablet). Fexofenadine HCL 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: 1-800-616-2471.
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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. COMPARE TO the active ingredient in ALLEGRA(R) ALLERGY 24 HOURFEXOFENADINE HYDROCHLORIDE USP 180 mg AntihistamineALLERGY RELIEF 24-HOUR Relief of:sneezing Runny nose Itchy, watery eyes Itchy nose or throatIndoor and OutdoorAllergy ReliefNon-DrowsyCapsule Shaped TabletsThis product is not manufactured or distributed by Chattem Inc., distributor of Allegra(R) Allergy 24 hourTAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDistributed by:MAJOR(R) PHARMACEUTICALS17177 Laurel Park Drive, Suite 233Livonia, MI 48152. sneezing Runny nose Itchy, watery eyes Itchy nose or throat.
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STORAGE AND HANDLING SECTION.
Other information. each tablet contain: sodium mgstore between 20 to 25C (68 to 77F)protect from excessive moisture this product meets the requirements of USP Dissolution Test 2. each tablet contain: sodium mg. store between 20 to 25C (68 to 77F). protect from excessive moisture this product meets the requirements of USP Dissolution Test 2.
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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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