DOSAGE & ADMINISTRATION SECTION.
Directions. do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take tablet with glass of water every 12 hours on an empty stomach; do not take more than tablets 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 Other informationsafety sealed: do not use if carton is opened or if individual blister units are torn or opened. store at 20-25C (68-77F).Meets USP dissolution test 7. do not divide, crush, chew or dissolve the tablet; swallow tablet whole. safety sealed: do not use if carton is opened or if individual blister units are torn or opened. store at 20-25C (68-77F).. Meets USP dissolution test 7.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid Questions or Comments call 1-855-274-4122 IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information. Distributed by: RUGBY(R) LABORATORIES Indianapolis, IN 46268(800) 616-2471 Made in India.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throattemporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergiesreduces swelling of nasal passagestemporarily relieves sinus congestion and pressuretemporarily restores freer breathing through the nose. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.
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OTC - ACTIVE INGREDIENT SECTION.
Drug Facts. Active ingredients (in each tablet) Fexofenadine HCl USP 60 mgPseudoephedrine HCl USP 120 mg.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have. heart diseasethyroid diseaseglaucomahigh blood pressurediabetestrouble urinating due to an enlarged prostate glandkidney disease. Your doctor should determine if you need different dose.. heart disease. thyroid disease. glaucoma. high blood pressure. diabetes. trouble urinating due to an enlarged prostate gland. kidney disease. Your doctor should determine if you need different dose.
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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 (1-800-222-1222) right away.
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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. AntihistamineNasal decongestant.
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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.symptoms do not improve within days or are accompanied by feveryou get nervous, dizzy, or sleepless. an allergic reaction to this product occurs. Seek medical help right away.. symptoms do not improve within days or are accompanied by fever. you get nervous, dizzy, or sleepless.
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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 antacids do not take with fruit juices (see Directions)the tablet coating may be seen in the stool (this is normal). Continue to take as directed (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). the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 2 10 Blister Carton. Rugby(R) Non-Drowsy NDC 0536-1431-34 Compare to the active ingredients in Allegra-D(R) 12 Hour Allergy Congestion Tablets Allergy Congestion Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets, USP 60 mg/120 mg Antihistamine and Nasal Decongestant 12 Hour Indoor Outdoor Relief of: Nasal and Sinus Congestion Due to Colds or AllergiesSneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies 20 Extended Release Tablets Nasal and Sinus Congestion Due to Colds or Allergies. Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies fexofenadine-fig1.
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WARNINGS SECTION.
Warnings. Do not useif you have ever had an allergic reaction to this product or any of its ingredientsif you are now taking prescription monoamine oxidase inhibitor (MAOI) certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product. if you have difficulty swallowing. if you have ever had an allergic reaction to this product or any of its ingredients. if you are now taking prescription monoamine oxidase inhibitor (MAOI) certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product. if you have difficulty swallowing.
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