Label: DAYQUIL AND NYQUIL VAPOCOOL SEVERE COLD AND FLU PLUS CONGESTION- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride kit

  • NDC Code(s): 69423-989-08, 69423-989-12, 69423-990-08, 69423-990-12, view more
    69423-991-24
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Vicks ® NyQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION

    Drug Facts

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Doxylamine succinate 12.5 mg
    Phenylephrine HCl 10 mg

    Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine
    Nasal 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


    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.
  • 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 DOCTOR/PHARMACIST

    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

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    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
    • only use the dose cup provided
    • do not exceed 4 doses per 24 hrs
    adults & children 12 yrs & over30 mL every 6 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use

  • Other information

    • each 30 mL contains: sodium 81 mg
    • store at no greater than 25°C and do not refrigerate
  • Inactive ingredients

    alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: Do not use if printed shrinkband on bottle is broken or missing.

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE,

    CINCINNATI OH 45202

  • SPL UNCLASSIFIED SECTION

    Vicks ® DayQuil™ VapoCOOL™ SEVERE COLD & FLU + CONGESTION

    Drug Facts

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

    Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation
    • minor aches & pains
    • headache
    • fever
    • sore throat
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

  • 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
    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.
  • Ask a doctor before use if you have

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

    taking the blood thinning drug warfarin.

  • When using this product,

    do not use more than directed.

  • 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

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    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
    • only use the dose cup provided
    • do not exceed 4 doses per 24 hrs
    adults & children 12 yrs & over30 mL every 4 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use

  • Other information

    • each 30 mL contains: sodium 81 mg
    • store at no greater than 25°C and do not refrigerate
  • Inactive ingredients

    alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: Do not use if printed shrinkband on bottle is broken or missing.

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE,

    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - Convenience Pack

    MAX STRENGTH

    COOLING RELIEF

    DAY & NIGHT PACK

    VICKS ®

    DAYQUIL NYQUIL

    VICKS ® DayQuil™ VapoCOOL™

    SEVERE COLD & FLU + CONGESTION

    Acetaminophen,Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr

    Headache, Fever, Sore Throat, Minor Aches & Pains

    Chest Congestion, Thins & Loosens Mucus

    Nasal Congestion, Sinus Pressure

    Cough

    Non-Drowsy

    Alcohol 10%

    Vicks ®NyQuil™ VapoCOOL™

    SEVERE COLD & FLU + CONGESTION

    Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr

    Headache, Fever, Sore Throat, Minor Aches & Pains

    Nasal Congestion & Sinus Pressure

    Sneezing, Runny Nose

    Cough

    Nighttime Relief

    Alcohol 10%

    2 BOTTLES - 1 DAYQUIL/1 NYQUIL; 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)

    991

  • INGREDIENTS AND APPEARANCE
    DAYQUIL AND NYQUIL VAPOCOOL SEVERE  COLD AND FLU PLUS CONGESTION
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-991
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-991-241 in 1 PACKAGE; Type 0: Not a Combination Product03/22/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 236 mL
    Part 21 BOTTLE, PLASTIC 236 mL
    Part 1 of 2
    DAYQUIL VAPOCOOL SEVERE  COLD AND FLU PLUS CONGESTION
    acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin solution
    Product Information
    Item Code (Source)NDC:69423-990
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorANISEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-990-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69423-990-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/21/2021
    Part 2 of 2
    NYQUIL VAPOCOOL SEVERE  COLD AND FLU PLUS CONGESTION
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution
    Product Information
    Item Code (Source)NDC:69423-989
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorANISEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-989-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69423-989-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/22/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)