TYLENOL COLD PLUS FLU SEVERE DAY AND TYLENOL COLD PLUS FLU PLUS COUGH NIGHT 2-PACK- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride kit

Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack by

Drug Labeling and Warnings

Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Tylenol® Cold plus Flu plus Cough
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+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

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Tylenol® Cold plus 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)

PRINCIPAL DISPLAY PANEL

NDC: 50580-526-01

DAYTIME
NIGHTTIME

PRINCIPAL DISPLAY PANEL

NDC: 50580-369-01

TYLENOL®
FOR ADULTS
COLD + FLU + COUGH

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

NIGHT
WILD BERRY
BURST

Alcohol 0.7%
8 fl oz (240 mL)

PRINCIPAL DISPLAY PANEL

NDC: 50580-403-08

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

DAY
NON-DROWSY
Warming
HONEY
LEMON

8 fl oz (240 mL)

INGREDIENTS AND APPEARANCE

TYLENOL COLD PLUS FLU SEVERE DAY AND TYLENOL COLD PLUS FLU PLUS COUGH NIGHT 2-PACK 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-526

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-526-01	1 in 1 PACKAGE	10/28/2019

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

Part 1 of 2

TYLENOL COLD PLUS FLU PLUS COUGH   NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution

Product Information
Item Code (Source)	NDC: 50580-369
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
acetic acid (UNII: Q40Q9N063P)
alcohol (UNII: 3K9958V90M)
anhydrous citric acid (UNII: XF417D3PSL)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C red no. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	BERRY (Berry Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-369-01	240 mL in 1 BOTTLE; 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	06/17/2019

Part 2 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/28/2019

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