Drug Facts

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Directions

DOSAGE & ADMINISTRATION SECTION

do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use

Other information

SPL UNCLASSIFIED SECTION

each 30 mL contains : potassium 35 mg, sodium 17 mg store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call 1-800-328-5259

Theraflu ExpressMax Nighttime Severe Cold & Cough

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to a cold: 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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Directions

DOSAGE & ADMINISTRATION SECTION

do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist. do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age Do not use

Other information

SPL UNCLASSIFIED SECTION

each 30 mL contains : potassium 35 mg, sodium 17 mg store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call 1-800-328-5259

Other Safety Information

OTHER SAFETY INFORMATION

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2019 GSK group of companies or its licensor. 13440

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-8125-16 THERAFLU ExpressMax DAYTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Cough • Nasal Congestion • Sore Throat Pain • Fever • Headache • Body Ache 8.3 FL OZ (245.5mL) Alcohol Free DAYTIME THERAFLU ExpressMax NIGHTTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Cough • Nasal Congestion • Sore Throat Pain • Fever • Headache • Body Ache • Runny Nose 8.3 FL OZ (245.5mL) Alcohol Free NIGHTTIME 2 – 8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL) Use Only As Directed

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-8127-08 THERAFLU ExpressMax DAYTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Cough • Nasal Congestion • Sore Throat Pain • Fever • Headache • Body Ache 8.3 FL OZ (245.5mL) Alcohol Free

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-8129-08 THERAFLU ExpressMax NIGHTTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Cough • Nasal Congestion • Sore Throat Pain • Fever • Headache • Body Ache • Runny Nose 8.3 FL OZ (245.5mL) Alcohol Free