OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have. liver diseaseheart diseasehigh blood pressurethyroid diseasediabetesglaucomatrouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitiscough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. liver disease. heart disease. high blood pressure. thyroid disease. diabetes. glaucoma. trouble urinating due to an enlarged prostate gland. breathing problem such as emphysema or chronic bronchitis. cough that occurs with too much phlegm (mucus). cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.
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DOSAGE & ADMINISTRATION SECTION.
Directions. do not use more than directedtake every hours, while symptoms persist. Do not take more than packets in 24 hours unless directed by doctor.AgeDoseadults and children12 years of age and overone packetchildren under12 years of agedo not usedissolve contents of one packet into oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.if using microwave, add contents of one packet to oz. of cool water; stir briskly before and after heating. Do not overheat.. do not use more than directed. take every hours, while symptoms persist. Do not take more than packets in 24 hours unless directed by doctor.. Age. Dose. adults and children. 12 years of age and over. one packet. children under. 12 years of age. do not use. dissolve contents of one packet into oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.. if using microwave, add contents of one packet to oz. of cool water; stir briskly before and after heating. Do not overheat.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms due to cold: minor aches and painsminor sore throat painheadachenasal and sinus congestionrunny nosesneezingitchy nose or throatitchy, watery eyes due to hay fevercough due to minor throat and bronchial irritation temporarily reduces fever. temporarily relieves these symptoms due to cold: minor aches and painsminor sore throat painheadachenasal and sinus congestionrunny nosesneezingitchy nose or throatitchy, watery eyes due to hay fevercough due to minor throat and bronchial irritation minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. runny nose. sneezing. itchy nose or throat. itchy, watery eyes due to hay fever. cough due to minor throat and bronchial irritation. temporarily reduces fever.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each packet). Acetaminophen 650 mgDiphenhydramine HCl 25 mgPhenylephrine HCl 10 mg.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are. taking sedatives or tranquilizerstaking the blood thinning drug warfarin. taking sedatives or tranquilizers. taking the blood thinning drug warfarin.
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OTC - DO NOT USE SECTION.
Do not use. in child under 12 years of ageif you are allergic to acetaminophenwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.with any other product containing diphenhydramine, even one used on the skinif 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.. in child under 12 years of age. if you are allergic to acetaminophen. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. with any other product containing diphenhydramine, even one used on the skin. 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.
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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 reducerAntihistamine/Cough suppressantNasal decongestant.
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OTC - QUESTIONS SECTION.
Questions or comments. call 1-855-328-5259.
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OTC - STOP USE SECTION.
Stop use and ask doctor if. nervousness, dizziness, or sleeplessness occursfever gets worse or lasts more than daysredness or swelling is presentnew symptoms occurpain, cough or nasal congestion gets worse or lasts more than dayscough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.. nervousness, dizziness, or sleeplessness occurs. fever gets worse or lasts more than days. redness or swelling is present. new symptoms occur. pain, cough or nasal congestion gets worse or lasts more than days. cough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.
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OTC - WHEN USING SECTION.
When using this product. do not exceed recommended dosageavoid alcoholic drinksmarked drowsiness may occuralcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machineryexcitability may occur, especially in children. do not exceed recommended dosage. avoid alcoholic drinks. marked drowsiness may occur. alcohol, sedatives and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery. excitability may occur, especially in children.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. THERAFLUSEVERE COLD RELIEFNIGHTTIMEHELPS YOU RESTAcetaminophenPain Reliever/Fever ReducerDiphenhydramine HClAntihistamine/Cough SuppressantPhenylephrine HClNasal DecongestantHot liquid therapy that relieves:Nasal and sinus congestionCoughSore throat painHeadacheRunny noseFeverHoney Lemon Flavor6 PACKETS62000000201494 Front Carton. Theraflu Severe Cold Relief Nightime packets.
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SPL UNCLASSIFIED SECTION.
Other information. each packet contains:potassium 10 mg, sodium 23 mg phenylketonurics:contains phenylalanine 13 mg per packet store at controlled room temperature 20-25C (68-77F). Protect product from heat and moisture.. each packet contains:potassium 10 mg, sodium 23 mg phenylketonurics:contains phenylalanine 13 mg per packet store at controlled room temperature 20-25C (68-77F). Protect product from heat and moisture.
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WARNINGS SECTION.
Warnings. Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddeningblistersrashIf skin reaction occurs, stop use and seek medical help right away.Sore throat warning:If sore throat is severe, persists for more than days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult doctor promptly. more than 4,000 mg of acetaminophen in 24 hours. with other drugs containing acetaminophen. or more alcoholic drinks every day while using this product. skin reddening. blisters. rash. Do not use. in child under 12 years of ageif you are allergic to acetaminophenwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.with any other product containing diphenhydramine, even one used on the skinif 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.. in child under 12 years of age. if you are allergic to acetaminophen. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. with any other product containing diphenhydramine, even one used on the skin. 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.. Ask doctor before use if you have. liver diseaseheart diseasehigh blood pressurethyroid diseasediabetesglaucomatrouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitiscough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. liver disease. heart disease. high blood pressure. thyroid disease. diabetes. glaucoma. trouble urinating due to an enlarged prostate gland. breathing problem such as emphysema or chronic bronchitis. cough that occurs with too much phlegm (mucus). cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask doctor or pharmacist before use if you are. taking sedatives or tranquilizerstaking the blood thinning drug warfarin. taking sedatives or tranquilizers. taking the blood thinning drug warfarin. When using this product. do not exceed recommended dosageavoid alcoholic drinksmarked drowsiness may occuralcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machineryexcitability may occur, especially in children. do not exceed recommended dosage. avoid alcoholic drinks. marked drowsiness may occur. alcohol, sedatives and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery. excitability may occur, especially in children. Stop use and ask doctor if. nervousness, dizziness, or sleeplessness occursfever gets worse or lasts more than daysredness or swelling is presentnew symptoms occurpain, cough or nasal congestion gets worse or lasts more than dayscough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.. nervousness, dizziness, or sleeplessness occurs. fever gets worse or lasts more than days. redness or swelling is present. new symptoms occur. pain, cough or nasal congestion gets worse or lasts more than days. cough comes back or occurs with rash or headache that lasts. 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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