Label: VICKS DAYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

  • NDC Code(s): 37000-810-01, 37000-810-04, 37000-810-08, 37000-810-12
  • 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

    Drug Facts

  • Active ingredients (in each 15 mL)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 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

    • adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product

    • child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product

    • taken with other drugs containing acetaminophen

    • adult has 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 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 5 days (children) or 7 days (adults)
    • 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.

  • OVERDOSAGE

    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 6 to under 12 yrs15 mL every 4 hrs
    children 4 to under 6 yrsask a doctor
    children under 4 yrsdo not use

  • Other information

    • each 15 mL contains: sodium 47 mg
    • store at no greater than 25ºC and do not refrigerate
  • Inactive ingredients

    citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: Do not use if printed shrinkband is broken or rmissing.

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

    VICKS®

    DayQuil™

    SEVERE

    COLD & FLU

    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 Free

    12 FL OZ (354 ml)

    810

  • INGREDIENTS AND APPEARANCE
    VICKS DAYQUIL  SEVERE COLD AND FLU
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-810
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-810-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2013
    2NDC:37000-810-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2013
    3NDC:37000-810-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2021
    4NDC:37000-810-044 in 1 PACKAGE07/13/2021
    430 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 DrugM01207/22/2013
    Labeler - The Procter & Gamble Manufacturing Company (004238200)