TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride kit

TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT by

Drug Labeling and Warnings

TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT 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 + FLU SEVERE NIGHT

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg	Antihistamine
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• for the temporary relief of the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sinus congestion and pressure
  • sneezing and runny nose
• helps clear nasal passages
• relieves cough to help you sleep
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 or emphysema
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma

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)

• adults and children 12 years and over:
  • take 2 caplets every 4 hours
  • swallow whole; do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours
• 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

anhydrous citric acid, carnauba wax, FD&C blue no. 1 aluminum lake, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, sodium benzoate, sodium citrate dihydrate, sodium starch glycolate, sucralose, titanium dioxide

Questions or comments?

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

SPL UNCLASSIFIED SECTION

TYLENOL® COLD + FLU SEVERE DAY

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	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

• for the temporary relief of 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. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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)

• adults and children 12 years and over:
  • take 2 caplets every 4 hours
  • swallow whole; do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours
• children under 12 years: ask a doctor

Other information

• each caplet contains: sodium 3 mg
• store between 20-25°C (68-77°F)
• do not use if blister unit is torn or broken

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 50580-414-04

TYLENOL®
FOR ADULTS

COLD + FLU
SEVERE

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

DAY

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

Actual
Size

16 CAPLETS

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

NIGHT

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

Actual
Size

8 CAPLETS

TOTAL 24 CAPLETS

INGREDIENTS AND APPEARANCE

TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-414

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-414-03	3 in 1 CELLO PACK	07/18/2016
1	NDC: 50580-414-01	1 in 1 CARTON
2	NDC: 50580-414-04	1 in 1 CARTON	12/21/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BLISTER PACK	8
Part 2	2 BLISTER PACK	16

Part 1 of 2

TYLENOL COLD PLUS FLU   SEVERE NIGHT
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)	Chlorpheniramine Maleate	2 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
carnauba wax (UNII: R12CBM0EIZ)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
polysorbate 80 (UNII: 6OZP39ZG8H)
potassium sorbate (UNII: 1VPU26JZZ4)
powdered cellulose (UNII: SMD1X3XO9M)
sodium benzoate (UNII: OJ245FE5EU)
trisodium citrate dihydrate (UNII: B22547B95K)
sodium starch glycolate type A potato (UNII: 5856J3G2A2)
sucralose (UNII: 96K6UQ3ZD4)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (Light blue)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	TYLENOL;1075
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341

Part 2 of 2

TYLENOL COLD PLUS FLU   SEVERE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated

Product Information
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
carnauba wax (UNII: R12CBM0EIZ)
croscarmellose sodium (UNII: M28OL1HH48)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
sucralose (UNII: 96K6UQ3ZD4)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	TYLENOL;SEVERE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/18/2016

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