Extra Strength TYLENOL Severe Cough Plus Sore Throat Day

Generic name: acetaminophen and dextromethorphan hydrobromide

Kenvue Brands LLC

Dosage Form

N/A

Manufacturer

Kenvue Brands LLC

Active ingredients

ACETAMINOPHEN1000 mg / 30 mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg / 30 mL

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily relieves these common cold/flu symptoms:
minor aches and pains
headache
sore throat
cough
temporarily reduces fever

do not exceed recommended dose

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

50580-140-08

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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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adults and children 12 years and over	take 30 mL in the dosing cup provided every 6 hours while symptoms last do not take more than 90 mL in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Active ingredients

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.do not take more than directed(see overdose warning) shake well before using mL = milliliter use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 yea…

Do not use if…Keep out of reach of children.

Ask a doctor before use if…pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be s…

Ask a doctor or pharmacist before use if…taking the blood thinning drug warfarin

Stop use and talk to a doctor if…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 oxidas…

Storage and handlingeach 30 mL contains: sodium 19 mg store between 20-25°C (68-77°F) do not use if neck band imprinted with “INSTANT COOLING SENSATION” or foil inner seal imprinted with “TYLENOL” is broken or missing

Package labelNEW NDC 50580-140-08 EXTRA STRENGHT TYLENOL ® FOR ADULTS SEVERE COUGH + SORE THROAT Acetaminophen, Dextromethorphan HBr, Pain Reliever-Fever Reducer, Cough Suppressant HEAD+BODY ACHES FEVER+ SORE THROAT COUGH DAY COOLING…