VICKS NYQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]

VICKS NYQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 37000-808-08, 37000-808-12, 37000-808-24, 37000-808-36
Set ID 11133d25-028b-4245-b2a0-11f6adaa9326
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 30 mL dose cup)Purpose
    Acetaminophen 650 mgPain reliever/fever reducer
    Dextromethorphan HBr 30 mgCough suppressant
    Doxylamine succinate 12.5 mgAntihistamine
  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
  • 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
    • 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

    • pain 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 the recommended dose 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 6 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 insure correct dosing
  • Other information

    • each 30 mL dose cup contains: sodium 44 mg
    • store at room temperature
  • Inactive ingredients

    alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, PEG-40 stearate, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, xanthan gum

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    Dist. by
    Procter & Gamble,
    Cincinnati OH 45202.

  • PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

    VICKS®

    NyQuil®

    COLD & FLU

    Nighttime Relief

    Acetaminophen, Doxylamine, Dextromethorphan

    • Aches, Fever & Sore Throat
    • Sneezing, Runny Nose
    • Cough

    Alcohol 10%

    8 FL OZ (236 ml)

    808

  • INGREDIENTS AND APPEARANCE
    VICKS NYQUIL  COLD AND FLU NIGHTTIME RELIEF
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-808
    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 HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRY, MENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-808-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2010
    2NDC:37000-808-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2010
    3NDC:37000-808-242 in 1 PACKAGE, COMBINATION06/01/2010
    3NDC:37000-808-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:37000-808-363 in 1 PACKAGE, COMBINATION06/01/2010
    4NDC:37000-808-12354 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 finalpart34106/01/2010
    Labeler - The Procter & Gamble Manufacturing Company (004238200)