VICKS DAYQUIL AND VICKS NYQUIL COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPA

VICKS DAYQUIL AND VICKS NYQUIL COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPA
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NDC 37000-033-24, 37000-555-12, 37000-807-12
Set ID 416c6674-e4aa-6375-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    NyQuil Cold & Flu

    Drug Facts

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 30 mg
    Doxylamine succinate 12.5 mg


    Pain reliever/ fever reducer
    Cough suppressant
    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & 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

    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
    • 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

    • 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

    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 & over 30 mL every 6 hrs
    children 4 to under 12 yrs ask a doctor
    children under 4 yrs do not use

  • Other information

    • each 30 mL tablespoon contains: potassium 5 mg, sodium 37 mg
    • store at room temperature and do not refrigerate
  • Inactive ingredients

    acesulfame potassium, alcohol, citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Yellow No. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati OH 45202

  • SPL UNCLASSIFIED SECTION

    DayQuil Cold & Flu

    Drug Facts

  • Active ingredients (in each 15 mL)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCI 5 mg

    Purpose

    Pain reliever/Fever reducer
    Cough suppressant
    Nasal decongestan

  • Uses

    temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever

  • Warnings

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if

    • adults take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
    • child take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
    • 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 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, 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 get worse or last 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.

    Overdose warning

    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 & over 30 mL every 4 hrs
    children 6 to under 12 yrs 15 mL every 4 hrs
    children 4 to under 6 yrs ask a doctor
    children under 4 yrs do not use

  • Other information

    • each 15 mL contains: sodium 46 mg
    • store at room temperature 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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    POWERFUL

    RELIEF

    Day or Night Pack

    VICKS ®

    DayQuil

    COLD & FLU

    Multi-Symptom Relief

    Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr,

    • Headache, Fever, Sore Throat,

      Minor Aches & Pains
    • Nasal Congestion
    • Cough


    DayQuil 12 FL OZ (354 ml) BOTTLE

    NyQuil

    COLD & FLU

    Nighttime Relief

    Acetaminophen,Doxylamine

    Succinate, Dextromethorphan HBr

    • Headache, Fever, Sore Throat

      Minor Aches & Pains
    • Sneezing, Runny Nose
    • Cough

    Alcohol 10%

    NyQuil 12 FL OZ (354 ml) BOTTLE

    TOTAL 24 FL OZ (708 ml)

    033

  • INGREDIENTS AND APPEARANCE
    VICKS DAYQUIL AND VICKS NYQUIL  COLD AND FLU
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-033
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-033-241 in 1 PACKAGE; Type 0: Not a Combination Product08/01/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 354 mL
    Part 21 BOTTLE, PLASTIC 354 mL
    Part 1 of 2
    VICKS DAYQUIL   COLD AND FLU MULTI-SYMPTOM RELIEF
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
    Product Information
    Item Code (Source)NDC:37000-555
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorAPRICOTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-555-12354 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 finalpart34106/22/2011
    Part 2 of 2
    VICKS NYQUIL  COLD AND FLU NIGHTTIME RELIEF
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate solution
    Product Information
    Item Code (Source)NDC:37000-807
    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
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorANISE, MENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-807-12354 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2013
    Labeler - The Procter & Gamble Manufacturing Company (004238200)