DOSAGE & ADMINISTRATION SECTION.

Directions. do not use more than directedmeasure the dose correctly using the enclosed dosing cuptake every hours in dosing cup provided, while symptoms persistdo not take more than doses (150 mL) in 24 hours unless directed by doctorAgeDoseAdults and children 12 years of age and over30 mLChildren under 12 years of agedo not use. do not use more than directed. measure the dose correctly using the enclosed dosing cup. take every hours in dosing cup provided, while symptoms persist. do not take more than doses (150 mL) in 24 hours unless directed by doctor.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate.

INDICATIONS & USAGE SECTION.

Uses. temporarily relieves these symptoms to cold: minor aches and painsminor sore throat painheadacherunny nosesneezingitchy nose or throatitchy, watery eyes due to hay fevercough due to minor throat and bronchial irritation temporarily reduces fever. temporarily relieves these symptoms to cold: minor aches and painsminor sore throat painheadacherunny 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. 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.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredients (in each 30 mL). Acetaminophen 650 mgDiphenhydramine HCl 25 mg.

OTC - ASK DOCTOR SECTION.

Ask doctor before use if you have. liver diseaseglaucomatrouble 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. 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.

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.

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 skinto sedate child or make child sleepy. 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. to sedate child or make child sleepy.

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 - PREGNANCY OR BREAST FEEDING SECTION.

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

OTC - PURPOSE SECTION.

Purposes. Pain reliever/Fever reducerAntihistamine/Cough suppressant.

OTC - QUESTIONS SECTION.

Questions or comments. 1-855-328-5259.

OTC - STOP USE SECTION.

Stop use and ask doctor if. fever gets worse or lasts more than daysredness or swelling is presentnew symptoms occurpain or cough gets worse or lasts more than dayscough comes back or occurs with rash or headache that lastsThese could be signs of serious condition.. fever gets worse or lasts more than days. redness or swelling is present. new symptoms occur. pain or cough gets worse or lasts more than days. cough comes back or occurs with rash or headache that lasts.

OTC - WHEN USING SECTION.

When using this product. avoid alcoholic drinksmarked drowsiness may occuralcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machineryexcitability may occur, especially in children. 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package/Label Principal Display Panel. MULTI-SYMPTOM COLD RELIEF THERAFLUSEVERECOLD RELIEFNIGHTTIMEAcetaminophenPain Reliever/Fever ReducerDiphenhydramine HClAntihistamine/Cough SuppressantHELPS YOU RESTPowerful formula that relieves:/ Cough/ Sore throat pain/ Head and body ache/ Fever/ Runny nose/ Sneezing8.3 FL OZ (245.5 mL)Berry FlavorTemporarily controls cough to help you rest. This is not sleep-aid.. Theraflu Severe Cold Relief Nighttime 8.3 oz.

SPL UNCLASSIFIED SECTION.

Other information. each 30 mL contains:potassium 30 mg, sodium 13 mg store at controlled room temperature 20-25C (68 77F). each 30 mL contains:potassium 30 mg, sodium 13 mg store at controlled room temperature 20-25C (68 77F).

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 skinto sedate child or make child sleepy. 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. to sedate child or make child sleepy. Ask doctor before use if you have. liver diseaseglaucomatrouble 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. 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. avoid alcoholic drinksmarked drowsiness may occuralcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machineryexcitability may occur, especially in children. 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. fever gets worse or lasts more than daysredness or swelling is presentnew symptoms occurpain or cough gets worse or lasts more than dayscough comes back or occurs with rash or headache that lastsThese could be signs of serious condition.. fever gets worse or lasts more than days. redness or swelling is present. new symptoms occur. pain or cough gets worse or lasts more than days. cough comes back or occurs with rash or headache that lasts. 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.