VICKS DAYQUIL TROPICAL AND VICKS NYQUIL CHERRY COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [THE PROCTER & GAMBLE MANUFACTUR

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  • VICKS DAYQUIL TROPICAL AND VICKS NYQUIL CHERRY COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [THE PROCTER & GAMBLE MANUFACTUR

VICKS DAYQUIL TROPICAL AND VICKS NYQUIL CHERRY COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [THE PROCTER & GAMBLE MANUFACTUR
PDF | XML
NDC 37000-034-24, 37000-550-12, 37000-565-12
Set ID 416dd077-686a-320c-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    NyQuil Cough

    Drug Facts

  • Active ingredients (in each 30 mL)

    Dextromethorphan HBr 30 mg
    Doxylamine succinate 12.5 mg

    Purpose

    Cough suppressant
    Antihistamine

  • Uses

    temporarily relieves common cold symptoms:

    • cough due to minor throat and bronchial irritation
    • runny nose and sneezing
  • Warnings

    Do not use

    • 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

    • 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.

    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

    cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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.

  • 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: sodium 36 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, 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 Cough

    Drug Facts

  • Active ingredients (in each 15 mL)

    Dextromethorphan HBr 15 mg

    Purpose

    Cough suppressant

  • Uses

    temporarily relieves cough due to minor throat & bronchial irritation associated with a cold

  • Warnings

    Do not use

    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

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    Stop use and ask a doctor if

    cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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.

  • 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 6-8 hrs
    children 6 to under 12 years 15 mL every 6-8 hours

    children 4 to under 6 years ask a doctor
    children under 4 yrs do not use

  • Other information

    • each 15 mL contains: sodium 15 mg
    • store at room temperature
    • does not meet USP requirements for light resistant packaging
  • Inactive ingredients

    citric acid, D&C Yellow No. 10, 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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    FAST COUGH

    RELIEF

    Day or Night

    VICKS ®

    DayQuil ™

    COUGH

    COUGH SUPPRESSANT

    Dextromethorphan HBr- Cough Suppressant

    8 HR

    Powerful Cough Relief

    for up to 8 hours

    • Non-Drowsy

    Soothing Tropical Blend

    Alcohol Free

    Antihistamine Free

    DayQuil 12 FL OZ (354 ml) BOTTLE



    NyQuil ™

    COUGH

    COUGH SUPPRESSANT

    Doxylamine Succinate - Antihistamine

    Dextromethorphan HBr - Cough Suppressant

    • Powerful Cough Relief so you can sleep
    • Nighttime Relief

    Soothing Cherry

    Alcohol 10%

    NyQuil 12 FL OZ (354 ml) BOTTLE

    TOTAL 24 FL OZ (708 ml)

    034

  • INGREDIENTS AND APPEARANCE
    VICKS DAYQUIL TROPICAL AND VICKS NYQUIL CHERRY  COUGH
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-034
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-034-241 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  COUGH
    dextromethorphan hydrobromide liquid
    Product Information
    Item Code (Source)NDC:37000-565
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorPINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-565-12354 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  COUGH
    dextromethorphan hydrobromide and doxylamine succinate liquid
    Product Information
    Item Code (Source)NDC:37000-550
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-550-12354 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2013
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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