Tylenol ® Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack

SPL UNCLASSIFIED SECTION

Tylenol ® Cold plus Flu plus Cough Night

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 15 mL) Purpose

Acetaminophen 325 mg Pain reliever/ fever reducer

Dextromethorphan HBr 10 mg Cough suppressant

Doxylamine Succinate 6.25 mg Antihistamine

Phenylephrine HCl 5 mg Nasal decongestant

OTC - PURPOSE SECTION

Uses

• temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatnasal congestionrunny nose and sneezingcoughsinus congestion and pressure
• helps clear nasal passages
• relieves cough to help you sleep
• 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

SPL UNCLASSIFIED SECTION

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

• skin reddening
• blisters
• rash

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
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• 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

These could be signs of a serious condition.

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)
• mL = milliliter
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Other information

• each 15 mL contains: sodium 5 mg
• store between 20-25°C (68-77°F). Do not refrigerate.
• do not use if neck band imprinted with "TYLENOL COLD+FLU+COUGH" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

acetic acid, alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

SPL UNCLASSIFIED SECTION

TYLENOL ® Cold plus Flu Severe

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 30 mL) Purpose

Acetaminophen 650 mg Pain reliever/ fever reducer

Dextromethorphan HBr 20 mg Cough suppressant

Guaifenesin 400 mg Expectorant

Phenylephrine HCl 10 mg Nasal decongestant

OTC - PURPOSE SECTION

Uses

• temporarily relieves the following cold/flu symptoms: minor aches and painsheadachesore throatnasal congestioncough
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• 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

SPL UNCLASSIFIED SECTION

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

• skin reddening
• blisters
• rash

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose

Stop use and ask a doctor if

These could be signs of a serious condition.

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)
• mL = milliliter
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Other information

• each 30 mL contains: sodium 10 mg
• store between 20-25°C (68-77°F).
• do not use if neck band imprinted with "WARMING SENSATION" or foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive ingredients

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose