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FDA LABEL GENERIC: Acetaminophen MFR: Kenvue Brands LLC

Apap 500 Mg / Chlorpheniramine Maleate 2 Mg / Dextromethorphan Hydrobromide 15 Mg Oral Tablet

EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT DAY

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains

■ headache

■ sore throat

■ cough

■ 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

■ 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.
■ if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

■ liver disease
■ persistent or chronic cough such as occurs with smoking, asthma or emphysema
■ cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dose

Stop use and ask a doctor 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 signs of a serious condition.

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

Keep out of reach of children.

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.

Directions

do not take more than directed (see overdose warning)
adults and children 12 years and over

■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets 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

Other information

■ store between 20 - 25°C (68 - 77°F)
do not use if blister unit is torn or broken

Inactive ingredients

carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT NIGHT

Drug Facts

Active ingredients (in each caplet)

Purpose

Acetaminophen 500 mg

Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg Antihistamine
Dextromethorphan HBr 15 mg Cough suppressant

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains

■ headache

■ sore throat

■ cough

■ sneezing and runny nose

■ 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

■ 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.
■ if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

■ liver disease

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

■ trouble urinating due to an enlarged prostate gland

■ persistent or chronic cough such as occurs with smoking, asthma or emphysema

■ cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

When using this product

■ do not exceed recommended dose

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor 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 signs of a serious condition.

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

Keep out of reach of children.

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.

Directions

do not take more than directed (see overdose warning)
adults and children 12 years and over

■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets 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

Other information

■ store between 20 - 25°C (68 - 77°F)
■ do not use if blister unit is torn or broken

Inactive ingredients

carnauba wax, FD&C Blue no.1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-551-01

EXTRA STRENGTH

TYLENOL ®
FOR ADULTS

SEVERE COUGH + SORE THROAT

NEW!

DOSAGE + DIRECTIONS

Acetaminophen, Dextromethorphan HBr
Pain Reliever-Fever Reducer, Cough Suppressant

DAY

HEAD + BODY ACHES FEVER + SORE THROAT COUGH

Actual Size

16 CAPLETS

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr

Pain Reliever-Fever Reducer, Antihistamine, Cough Suppressant

NIGHT

HEAD + BODY ACHES FEVER + SORE THROAT COUGH RUNNY NOSE

Actua Size

8 CAPLETS

TOTAL 24 CAPLETS