FDA Label for Extra Strength Tylenol Cold Plus Flu Multi-action Day/night

View Indications, Usage & Precautions

Extra Strength Tylenol Cold Plus Flu Multi-action Day/night Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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TYLENOL^®COLD + FLU MULTI-ACTION DAY

Drug Facts

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.

TYLENOL^®COLD + FLU MULTI-ACTION NIGHT

Drug Facts

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.

Otc - Purpose

Active ingredients (in each caplet)	Purpose
Acetaminophen 500 mg	Pain reliever/fever reducer
Dextromethorphan HBr 15 mg	Cough suppressant
Pseudoephedrine HCl 30 mg	Nasal decongestant

Active ingredients (in each caplet)	Purpose
Acetaminophen 500 mg	Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg	Antihistamine
Dextromethorphan HBr 15 mg	Cough suppressant
Pseudoephedrine HCl 30 mg	Nasal decongestant

Uses

temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough
- sinus congestion and pressure
- helps clear nasal passages
- promotes nasal and sinus drainage
- temporarily reduces fever

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

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

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

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 or emphysema
cough that occurs with too much phlegm (mucus)

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 or emphysema
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
glaucoma

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product do not exceed recommended dose

Stop Use And Ask A Doctor If

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

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

These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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

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

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)

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

Principal Display Panel

NEW
NDC 50580-374-01

Extra Strength
TYLENOL^®
FOR ADULTS

COLD + FLU MULTI-ACTION

Acetaminophen
Dextromethorphan HBr, Pseudoephedrine HCl
Pain Reliever-Fever Reducer, Cough Suppressant, Nasal Decongestant

DAY

HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION

Actual Size

16 CAPLETS;

Acetaminophen
Chlorpheniramine Maleate, Dextromethorphan HBr, Pseudoephedrine HCl
Pain Reliever-Fever Reducer, Antihistamine, Cough Suppressant, Nasal Decongestant

NIGHT

HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH • NASAL CONGESTION
RUNNY NOSE