DOSAGE & ADMINISTRATION SECTION.
Directions. odo not use more than directedoadults and children 12 years of age and over:otake caplets every 4-6 hoursoswallow whole do not crush, chew, or dissolveodo not take more than 10 caplets in 24 hoursochildren under 12 years of age: ask doctor. odo not use more than directed. oadults and children 12 years of age and over:otake caplets every 4-6 hoursoswallow whole do not crush, chew, or dissolveodo not take more than 10 caplets in 24 hours. otake caplets every 4-6 hours. oswallow whole do not crush, chew, or dissolve. odo not take more than 10 caplets in 24 hours. ochildren 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. otemporarily relieves these symptoms of hay fever or other upper respiratory allergies:osinus congestion and pressureorunny nose and sneezingominor aches and painsonasal congestionoheadacheotemporarily relieves these additional symptoms of hay fever:oitching of the nose or throatoitchy, watery eyesohelps clear nasal passagesohelps decongest sinus openings and passages. otemporarily relieves these symptoms of hay fever or other upper respiratory allergies:. osinus congestion and pressure. orunny nose and sneezing. ominor aches and pains. onasal congestion. oheadache. otemporarily relieves these additional symptoms of hay fever:. oitching of the nose or throat. oitchy, watery eyes. ohelps clear nasal passages. ohelps 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. odifficulty in urination due to enlargement of the prostate glandohigh blood pressureoa breathing problem such as emphysema or chronic bronchitisoheart diseaseoliver diseaseothyroid diseaseoglaucomaodiabetes. odifficulty in urination due to enlargement of the prostate gland. ohigh blood pressure. oa breathing problem such as emphysema or chronic bronchitis. oheart disease. oliver disease. othyroid disease. oglaucoma. odiabetes.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are. otaking the blood thinning drug warfarinotaking sedatives or tranquilizers. otaking the blood thinning drug warfarin. otaking sedatives or tranquilizers.
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OTC - DO NOT USE SECTION.
Do not use. owith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.oif 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.oif you have ever had an allergic reaction to this product or any of its ingredients. owith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. oif 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.. oif 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. onervousness, dizziness, or sleeplessness occuropain or nasal congestion gets worse or lasts more than daysonew symptoms occurofever gets worse or lasts more than days oredness or swelling is present These could be signs of serious condition.. onervousness, dizziness, or sleeplessness occur. opain or nasal congestion gets worse or lasts more than days. onew symptoms occur. ofever gets worse or lasts more than days oredness or swelling is present. These could be signs of serious condition.
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OTC - WHEN USING SECTION.
When using this product. odo not exceed recommended dosageoexcitability may occur, especially in childrenoalcohol, sedatives, and tranquilizers may increase drowsinessoavoid alcoholic beverages ouse caution when driving motor vehicle or operating machinery odrowsiness may occur. odo not exceed recommended dosage. oexcitability may occur, especially in children. oalcohol, sedatives, and tranquilizers may increase drowsiness. oavoid alcoholic beverages ouse caution when driving motor vehicle or operating machinery odrowsiness may occur.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. NDC 0135-0578-03FLONASEHEADACHE &ALLERGY RELIEFNEW INGREDIENTSAcetaminophen 325 mg Pain Reliever/Fever ReducerChlorpheniramine Maleate mg AntihistaminePhenylephrine HCI mg Nasal DecongestantFAST RELIEF FROMoAllergy SymptomsoHeadache PainoNasal Congestion96 CAPLETSB-0630-778-46 ORG Front Carton oAllergy Symptoms. oHeadache Pain. oNasal 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. ostore at controlled room temperature 20-25C (68-77F). ostore at controlled room temperature 20-25C (68-77F).
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WARNINGS SECTION.
Warnings. Liver warning: This product contains acetaminophen. Severe liver damagemay occur if you takeomore than 4,000 mg of acetaminophen in 24 hoursowith other drugs containing acetaminopheno3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptomsmay include:oblistersorashoskin reddeningIf skin reaction occurs, stop use and seek medical help right away.. omore than 4,000 mg of acetaminophen in 24 hoursowith other drugs containing acetaminopheno3 or more alcoholic drinks every day while using this product. owith other drugs containing acetaminophen. o3 or more alcoholic drinks every day while using this product. oblisters. orash. oskin reddening. Do not use. owith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.oif 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.oif you have ever had an allergic reaction to this product or any of its ingredients. owith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. oif 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.. oif you have ever had an allergic reaction to this product or any of its ingredients. Ask doctor before use if you have. odifficulty in urination due to enlargement of the prostate glandohigh blood pressureoa breathing problem such as emphysema or chronic bronchitisoheart diseaseoliver diseaseothyroid diseaseoglaucomaodiabetes. odifficulty in urination due to enlargement of the prostate gland. ohigh blood pressure. oa breathing problem such as emphysema or chronic bronchitis. oheart disease. oliver disease. othyroid disease. oglaucoma. odiabetes. Ask doctor or pharmacist before use if you are. otaking the blood thinning drug warfarinotaking sedatives or tranquilizers. otaking the blood thinning drug warfarin. otaking sedatives or tranquilizers. When using this product. odo not exceed recommended dosageoexcitability may occur, especially in childrenoalcohol, sedatives, and tranquilizers may increase drowsinessoavoid alcoholic beverages ouse caution when driving motor vehicle or operating machinery odrowsiness may occur. odo not exceed recommended dosage. oexcitability may occur, especially in children. oalcohol, sedatives, and tranquilizers may increase drowsiness. oavoid alcoholic beverages ouse caution when driving motor vehicle or operating machinery odrowsiness may occur. Stop use and ask doctor if. onervousness, dizziness, or sleeplessness occuropain or nasal congestion gets worse or lasts more than daysonew symptoms occurofever gets worse or lasts more than days oredness or swelling is present These could be signs of serious condition.. onervousness, dizziness, or sleeplessness occur. opain or nasal congestion gets worse or lasts more than days. onew symptoms occur. ofever gets worse or lasts more than days oredness 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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