TYLENOL COLD PLUS FLU PLUS COUGH  NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Tylenol Cold + Flu + Cough Night

Drug Facts

Active ingredients (in each 15 mL)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine Succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

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

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 yearsask a doctor

Other information

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)

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

NIGHT

WILD BERRY
BURST

Alcohol 0.7%
8 fl oz (240 mL)

PRINCIPAL DISPLAY PANEL
TYLENOL COLD PLUS FLU PLUS COUGH   NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-369
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg  in 15 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 15 mL
Doxylamine Succinate (UNII: V9BI9B5YI2) (doxylamine - UNII:95QB77JKPL) Doxylamine Succinate6.25 mg  in 15 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore    
ShapeSize
FlavorBERRY (Berry Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-369-01240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/17/2019
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 5/2019
Document Id: ec2b0f73-44d3-4cfe-b9fb-39adac987116
Set id: e85e5eb9-3ecf-4784-999e-111e38e306f5
Version: 1
Effective Time: 20190516
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division