TYLENOL COLD PLUS FLU SEVERE AND TYLENOL COLD MAX COPACK- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride kit

TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack by

Drug Labeling and Warnings

TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TYLENOL Cold + Flu Severe

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 15 mL)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
• 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

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
• 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)

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

• 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.

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

• adults and children 12 years and over:
  • take 30 mL in the dosing cup provided every 4 hours while symptoms last
  • do not take more than 150 mL in 24 hours, unless directed by a doctor
• children under 12 years: ask a doctor

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 SEVERE" or foil inner seal imprinted with "SAFETY SEAL®" 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

Questions or comments?

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

TYLENOL COLD MAX NIGHT

Drug Facts

ACTIVE INGREDIENT

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

Uses

• temporarily relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • runny nose and sneezing
  • cough
  • sinus 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

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
• 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

• 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.

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

• adults and children 12 years and over:
  • take 30 mL in the dosing cup provided every 4 hours while symptoms last
  • do not take more than 150 mL in 24 hours, unless directed by a doctor
• children under 12 years: ask a doctor

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 MAX" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

DAYTIME

TYLENOL®
FOR ADULTS

COLD + FLU SEVERE

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever-–Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant

• ✔ HEAD + BODY ACHES
• ✔ FEVER + SORE THROAT
• ✔ COUGH
• ✔ NASAL CONGESTION
• ✔ MUCUS + CHEST CONGESTION

Warming
HONEY
LEMON

8 Fl OZ (240mL)

NIGHTTIME

NDC: 50580-231-01

TYLENOL®
FOR ADULTS

COLD MAX

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine, Nasal Decongestant

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

COOL
BURST®

Alcohol 0.7%

8 Fl OZ (240mL)

INGREDIENTS AND APPEARANCE

TYLENOL COLD PLUS FLU SEVERE AND TYLENOL COLD MAX COPACK 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-231

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-231-01	1 in 1 PACKAGE	08/20/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BOTTLE, PLASTIC	480 mL
Part 2	1 BOTTLE, PLASTIC	240 mL

Part 1 of 2

TYLENOL COLD PLUS FLU SEVERE 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

Product Information
Item Code (Source)	NDC: 50580-403
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg  in 15 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg  in 15 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg  in 15 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C red no. 40 (UNII: WZB9127XOA)
FD&C yellow no. 6 (UNII: H77VEI93A8)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	BROWN, YELLOW (Amber colored)	Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-403-08	240 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/05/2010

Part 2 of 2

TYLENOL COLD MAX   NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution

Product Information
Item Code (Source)	NDC: 50580-571
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg  in 15 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg  in 15 mL
Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL)	Doxylamine Succinate	6.25 mg  in 15 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
alcohol (UNII: 3K9958V90M)
anhydrous citric acid (UNII: XF417D3PSL)
FD&C blue no. 1 (UNII: H3R47K3TBD)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	BERRY, MINT (cooling berry mint flavored)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-571-01	240 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/13/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/20/2018

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)