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Vicks NyQuil Severe Cold and Flu

Medically reviewed on December 7, 2016

Dosage form: solution
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL, DOXYLAMINE SUCCINATE 12.5mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 30mL, ACETAMINOPHEN 650mg in 30mL
Labeler: The Procter & Gamble Manufacturing Company
NDC Code: 37000-815

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.

Vicks ® NyQuil ® Severe

Cold & Flu

Drug Facts

Active ingredients (in each 30 mL dose cup)Purpose
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Doxylamine succinate 12.5 mgAntihistamine
Phenylephrine HCl 10 mgNasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • 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.
  • to make a child sleep

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet

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

When using this product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • 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

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • take only as directed - see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over30 mL (2 TBSP) every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
  • when using other DayQuil ® or NyQuil products, carefully read each label to ensure correct dosing

Other information
  • each 30 mL dose cup contains: sodium 81 mg
  • store at room temperature

Inactive ingredients

alcohol, citric acid, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Green No. 3, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions?

1-800-362-1683

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

MAX
STRENGTH

VICKS®

NyQuil®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl,
Doxylamine Succinate, Dextromethorphan HBr

  • Headache, Fever, Sore Throat,
    Minor Aches & Pains
  • Nasal/Sinus Congestion
    & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief
Alcohol 10%

12 FL OZ
(354 ml)

VICKS NYQUIL  SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-815
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CITRIC ACID MONOHYDRATE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
FD&C GREEN NO. 3 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorANISEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-815-08236 mL in 1 BOTTLE, PLASTIC
2NDC:37000-815-12354 mL in 1 BOTTLE, PLASTIC
3NDC:37000-815-242 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION
3NDC:37000-815-12354 mL in 1 BOTTLE, PLASTIC
4NDC:37000-815-363 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION
4NDC:37000-815-12354 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/21/2014
Labeler - The Procter & Gamble Manufacturing Company (004238200)

 
The Procter & Gamble Manufacturing Company

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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