DOSAGE & ADMINISTRATION SECTION.
Directions. do not use more than directedadults and children 12 years of age and over: take caplets every 4-6 hoursswallow whole do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hours children under 12 years of age: ask doctor. do not use more than directed. adults and children 12 years of age and over: take caplets every 4-6 hoursswallow whole do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hours take caplets every 4-6 hours. swallow whole do not crush, chew, or dissolve. do not take more than 10 caplets in 24 hours. children under 12 years of age: ask doctor.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. benzyl alcohol, crospovidone, magnesium stearate, microcrystalline cellulose, modified corn starch, natural flavor, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, purified water, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms of hay fever or other upper respiratory allergies:sinus congestion and pressurerunny nose and sneezingminor aches and painsnasal congestionheadachetemporarily relieves these additional symptoms of hay fever:itching of the nose or throatitchy, watery eyeshelps clear nasal passageshelps decongest sinus openings and passages. temporarily relieves these symptoms of hay fever or other upper respiratory allergies:. sinus congestion and pressure. runny nose and sneezing. minor aches and pains. nasal congestion. headache. temporarily relieves these additional symptoms of hay fever:. itching of the nose or throat. itchy, watery eyes. helps clear nasal passages. helps decongest sinus openings and passages.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each caplet). Acetaminophen 325 mgChlorpheniramine maleate mgPhenylephrine HCl mg.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have. difficulty in urination due to enlargement of the prostate glandhigh blood pressurea breathing problem such as emphysema or chronic bronchitisheart diseaseliver diseasethyroid diseaseglaucomadiabetes. difficulty in urination due to enlargement of the prostate gland. high blood pressure. breathing problem such as emphysema or chronic bronchitis. heart disease. liver disease. thyroid disease. glaucoma. diabetes.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are. taking the blood thinning drug warfarintaking sedatives or tranquilizers. taking the blood thinning drug warfarin. taking sedatives or tranquilizers.
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OTC - DO NOT USE SECTION.
Do not use. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.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 ever had an allergic reaction to this product or any of its ingredients. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. 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 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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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.
Purposes. Pain reliever/Fever reducerAntihistamineNasal decongestant.
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OTC - QUESTIONS SECTION.
Questions or comments. 1-855-328-5259.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. nervousness, dizziness, or sleeplessness occurpain or nasal congestion gets worse or lasts more than daysnew symptoms occurfever gets worse or lasts more than daysredness or swelling is presentThese could be signs of serious condition.. nervousness, dizziness, or sleeplessness occur. pain or nasal congestion gets worse or lasts more than days. new symptoms occur. fever gets worse or lasts more than days. redness or swelling is present. These could be signs of serious condition.
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OTC - WHEN USING SECTION.
When using this product. do not exceed recommended dosageexcitability may occur, especially in childrenalcohol, sedatives, and tranquilizers may increase drowsinessavoid alcoholic beveragesuse caution when driving motor vehicle or operating machinerydrowsiness may occur. do not exceed recommended dosage. excitability may occur, especially in children. alcohol, sedatives, and tranquilizers may increase drowsiness. avoid alcoholic beverages. use caution when driving motor vehicle or operating machinery. drowsiness may occur.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. NDC 0135-0578-03FLONASEHEADACHE &ALLERGY RELIEFNEW INGREDIENTSAcetaminophen 325 mgPain Reliever/Fever Reducer Chlorpheniramine Maleate mgAntihistamine Phenylephrine HCI mgNasal Decongestant FAST RELIEF FROMAllergy SymptomsHeadache PainNasal Congestion96CAPLETS B-0630-778-46 ORG Front Carton. Allergy Symptoms. Headache Pain. Nasal Congestion. B-0630-778-46 Flonase 96 Caplets.
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SPL UNCLASSIFIED SECTION.
Additional Information. KEEP CARTON FOR COMPLETE INFORMATIONDo not use if blister is broken or damaged.Distributed by:GSK Consumer HealthcareWarren, NJ 07059Trademarks are owned by or licensed to the GSK group of companies.(C)2022 GSK group of companies or its licensor.
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STORAGE AND HANDLING SECTION.
Other information. store at controlled room temperature 20-25C (68-77F). store at controlled room temperature 20-25C (68-77F).
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WARNINGS SECTION.
Warnings. Liver warning:This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:blistersrashskin reddeningIf skin reaction occurs, stop use and seek medical help right away.. more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product with other drugs containing acetaminophen. or more alcoholic drinks every day while using this product. blisters. rash. skin reddening. Do not use. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.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 ever had an allergic reaction to this product or any of its ingredients. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. 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 ever had an allergic reaction to this product or any of its ingredients. Ask doctor before use if you have. difficulty in urination due to enlargement of the prostate glandhigh blood pressurea breathing problem such as emphysema or chronic bronchitisheart diseaseliver diseasethyroid diseaseglaucomadiabetes. difficulty in urination due to enlargement of the prostate gland. high blood pressure. breathing problem such as emphysema or chronic bronchitis. heart disease. liver disease. thyroid disease. glaucoma. diabetes. Ask doctor or pharmacist before use if you are. taking the blood thinning drug warfarintaking sedatives or tranquilizers. taking the blood thinning drug warfarin. taking sedatives or tranquilizers. When using this product. do not exceed recommended dosageexcitability may occur, especially in childrenalcohol, sedatives, and tranquilizers may increase drowsinessavoid alcoholic beveragesuse caution when driving motor vehicle or operating machinerydrowsiness may occur. do not exceed recommended dosage. excitability may occur, especially in children. alcohol, sedatives, and tranquilizers may increase drowsiness. avoid alcoholic beverages. use caution when driving motor vehicle or operating machinery. drowsiness may occur. Stop use and ask doctor if. nervousness, dizziness, or sleeplessness occurpain or nasal congestion gets worse or lasts more than daysnew symptoms occurfever gets worse or lasts more than daysredness or swelling is presentThese could be signs of serious condition.. nervousness, dizziness, or sleeplessness occur. pain or nasal congestion gets worse or lasts more than days. new symptoms occur. fever gets worse or lasts more than days. redness or swelling is present. These could be signs of serious condition.. 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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