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FDA LABEL GENERIC: Acetaminophen MFR: Haleon US Holdings LLC

1 Daytime (acetaminophen 650 Mg / Dextromethorphan Hbr 20 Mg / Phenylephrine Hcl 10 Mg In 30 Ml Oral Solution) / 1 Nighttime (acetaminophen 650 Mg / Diphenhydramine Hcl 25 Mg / Phenylephrine Hcl 10 Mg In 30 Ml Oral Solution) Pack

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

INDICATIONS AND USAGE

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

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.

Do Not Use

in a 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 a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a 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.

DOSAGE AND ADMINISTRATION

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

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

call 1-800-328-5259

Theraflu ExpressMax Nighttime Severe Cold & Cough

Drug Facts

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Pain Reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

INDICATIONS AND USAGE

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

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.

Do not use

in a 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 a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAO, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a 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 a doctor or pharmacist before use if you are

taking sedatives or tranquilizers taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a 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.

DOSAGE AND ADMINISTRATION

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

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

call 1-800-328-5259

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

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

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

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