DOSAGE & ADMINISTRATION SECTION.


Directions. odo not use more than directedoadults and children 12 years of age and over: take caplets every hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by doctorochildren under 12 years of age: do not use. odo not use more than directed. oadults and children 12 years of age and over: take caplets every hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by doctor. ochildren under 12 years of age: do not use.

INULLCTIVE INGREDIENT SECTION.


Inactive ingredients. Benzoic acid, croscarmellose sodium, ethanol, FD&C blue no.2 aluminum lake, ferrosoferric oxide, flavors, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicone dioxide, stearic acid, sucralose, titanium dioxide.

INDICATIONS & USAGE SECTION.


Uses. otemporarily relieves these symptoms due to cold:ominor aches and painsominor sore throat painoheadacheonasal and sinus congestionorunny noseosneezingoitchy nose or throatoitchy, watery eyes due to hay feverocough due to minor throat and bronchial irriationotemporarily reduces fever. otemporarily relieves these symptoms due to cold:ominor aches and painsominor sore throat painoheadacheonasal and sinus congestionorunny noseosneezingoitchy nose or throatoitchy, watery eyes due to hay feverocough due to minor throat and bronchial irriation. ominor aches and pains. ominor sore throat pain. oheadache. onasal and sinus congestion. orunny nose. osneezing. oitchy nose or throat. oitchy, watery eyes due to hay fever. ocough due to minor throat and bronchial irriation. otemporarily reduces fever.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient. Acetaminophen 325 mgDiphenhydramine HCl 12.5 mgPhenylephrine HCl mg.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if you have oliver diseaseoheart diseaseohigh blood pressureothyroid diseaseodiabetesoglaucomaotrouble urinating due to an enlarged prostate glandoa breathing problem such as emphysema or chronic bronchitisocough that occurs with too much phlegm (mucus)ocough that lasts or is chronic such as occurs with smoking, asthma or emphysema. oliver disease. oheart disease. ohigh blood pressure. othyroid disease. odiabetes. oglaucoma. otrouble urinating due to an enlarged prostate gland. oa breathing problem such as emphysema or chronic bronchitis. ocough that occurs with too much phlegm (mucus). ocough that lasts or is chronic such as occurs with smoking, asthma or emphysema.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are otaking sedatives or tranquilizersotaking the blood thinning drug warfarin. otaking sedatives or tranquilizers. otaking the blood thinning drug warfarin.

OTC - DO NOT USE SECTION.


Do not use oin child under 12 years of ageif you are allergic to acetaminophenowith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.owith any product containing diphenhydramine, even one used on the skinoif 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.. oin child under 12 years of ageif you are allergic to acetaminophen. owith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. owith any product containing diphenhydramine, even one used on the skin. 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.

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.

OTC - PREGNULLNCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding, Ask health professional before use.

OTC - PURPOSE SECTION.


Purpose. Pain reliever/fever reducerAntihistamine/cough suppressantNasal decongestant.

OTC - QUESTIONS SECTION.


Questions or Comments. call 1-800-452-0051.

OTC - STOP USE SECTION.


Stop use and ask doctor if onervousness, dizziness, or sleeplessness occursofever gets worse or lasts more than daysoredness or swelling is presentonew symptoms occuropain, cough or nasal congestion gets worse or lasts more than daysocough comes back or occurs with rash or headache that lasts. These could be signs of serious condition. onervousness, dizziness, or sleeplessness occurs. ofever gets worse or lasts more than days. oredness or swelling is present. onew symptoms occur. opain, cough or nasal congestion gets worse or lasts more than days. ocough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.

OTC - WHEN USING SECTION.


When using this product odo not exceed recommended dosageoavoid alcoholic drinksomarked drowsiness may occuroalcohol, sedatives and tranquilizers may increase drowsinessobe careful when driving motor vehicle or operation machineryoexcitability may occur, especially in children. odo not exceed recommended dosage. oavoid alcoholic drinks. omarked drowsiness may occur. oalcohol, sedatives and tranquilizers may increase drowsiness. obe careful when driving motor vehicle or operation machinery. oexcitability may occur, especially in children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Principal Display Panel NDC 0067-8137-20Theraflu(R) Express Max(TM)NIGHTTIMESEVERE COLD COUGHNEWWARMING RELIEF(TM) FORMULAACETAMINOPHEN PAIN RELIEVER/FEVER REDUCERDIPHENHYDRAMINE HCl ANTIHISTAMINE/COUGH SUPPRESSANTPEHNYLEPHRINE HCl NULLSAL DECONGESTANToNULLSAL CONGESTION SORE THROAT FEVER BODY ACHEoRUNNY NOSE HEADACHE COUGH 20 COATED CAPLETSMaximum Strength per hour dose.TAMPER EVIDENT FEATURE:THERAFLU(R) EXPRESSMAX(TM) CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.Distributed by: GSK Consumer Healthcare, Warren, NJ 07059Trademarks are owned by or licensed to the GSK group of companies.(C)2016 GSK group of companies or its licensor. All rights reserved.www.theraflu.com46171251. oNULLSAL CONGESTION SORE THROAT FEVER BODY ACHE. oRUNNY NOSE HEADACHE COUGH Theraflu Expressmax Nighttime Severe Cold and Cough caplet carton.

SPL UNCLASSIFIED SECTION.


Other information. ostore at controlled room temperature 20-25C (68-77F). ostore at controlled room temperature 20-25C (68-77F).

WARNINGS SECTION.


Warnings. Liver warning: This product ocontains acetaminophen. Severe lever damage may 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. Symptoms may include:oskin reddening oblistersorashIf 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.. omore than 4,000 mg of acetaminophen in 24 hours. owith other drugs containing acetaminophen. o3 or more alcoholic drinks every day while using this product. oskin reddening oblisters. orash. Do not use oin child under 12 years of ageif you are allergic to acetaminophenowith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.owith any product containing diphenhydramine, even one used on the skinoif 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.. oin child under 12 years of ageif you are allergic to acetaminophen. owith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. owith any product containing diphenhydramine, even one used on the skin. 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.. Ask doctor before use if you have oliver diseaseoheart diseaseohigh blood pressureothyroid diseaseodiabetesoglaucomaotrouble urinating due to an enlarged prostate glandoa breathing problem such as emphysema or chronic bronchitisocough that occurs with too much phlegm (mucus)ocough that lasts or is chronic such as occurs with smoking, asthma or emphysema. oliver disease. oheart disease. ohigh blood pressure. othyroid disease. odiabetes. oglaucoma. otrouble urinating due to an enlarged prostate gland. oa breathing problem such as emphysema or chronic bronchitis. ocough that occurs with too much phlegm (mucus). ocough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask doctor or pharmacist before use if you are otaking sedatives or tranquilizersotaking the blood thinning drug warfarin. otaking sedatives or tranquilizers. otaking the blood thinning drug warfarin. When using this product odo not exceed recommended dosageoavoid alcoholic drinksomarked drowsiness may occuroalcohol, sedatives and tranquilizers may increase drowsinessobe careful when driving motor vehicle or operation machineryoexcitability may occur, especially in children. odo not exceed recommended dosage. oavoid alcoholic drinks. omarked drowsiness may occur. oalcohol, sedatives and tranquilizers may increase drowsiness. obe careful when driving motor vehicle or operation machinery. oexcitability may occur, especially in children. Stop use and ask doctor if onervousness, dizziness, or sleeplessness occursofever gets worse or lasts more than daysoredness or swelling is presentonew symptoms occuropain, cough or nasal congestion gets worse or lasts more than daysocough comes back or occurs with rash or headache that lasts. These could be signs of serious condition. onervousness, dizziness, or sleeplessness occurs. ofever gets worse or lasts more than days. oredness or swelling is present. onew symptoms occur. opain, cough or nasal congestion gets worse or lasts more than days. ocough 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.