Label: VICKS DAYQUIL AND VICKS NYQUIL ELDERBERRY COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate kit

  • NDC Code(s): 84126-307-12, 84126-308-12, 84126-309-24
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 20, 2024

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

  • SPL UNCLASSIFIED SECTION

    VICKS ®DayQuil™ ELDERBERRY COLD & FLU

    Drug Facts

  • Active ingredients (in each 15 mL)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg

    Purpose

    Pain reliever/ fever reducer
    Cough suppressant

  • Uses

    temporarily relieves common cold/flu symptoms:

    • 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

    • 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 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)
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

  • Stop use and ask a doctor if

    • pain 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.

  • PREGNANCY OR BREAST FEEDING

    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 & 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 13 mg
    • store at no greater than 25°C and do not refrigerate
  • Inactive ingredients

    citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor (with elderberry), glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, water, xanthan gum

  • 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® NyQuil™ ELDERBERRY COLD & FLU

    Drug Facts

  • Active ingredients (in each 15 mL)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Purpose

    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 & sneezing

  • 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 eah) 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 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
  • 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 dowsiness 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 get 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.

  • PREGNANCY OR BREAST FEEDING

    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 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 13 mg
    • store at no greater than 25⁰C  and do not refrigerate

  • Inactive ingredients

    citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor (with elderberry), glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, water, xanthan gum

  • 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 - Kit Carton

    POWERFUL RELIEF

    BLACK ELDERBERRY FLAVORED

    Vicks DayQuil and NyQuil ELDERBERRY

    COLD & FLU

    Vicks DayQuil ELDERBERRY

    COLD & FLU

    THE DAYTIME, COUGHING, ACHING, SORE THROAT, FEVER, POWER THROUGH YOUR DAY, MEDICINE.

    Acetaminophen, Dextromethorphan HBr

    Headache, Fever, Sore Throat,

    Minor Aches & Pains

    Cough

    Vicks NyQuil ELDERBERRY

    COLD & FLU

    THE NIGHTTIME, SNIFFLING, SNEEZING, COUGHING, ACHING, FEVER, BEST SLEEP WITH A COLD, MEDICINE.

    Acetaminophen, Dextromethorphan HBr, Doxylamine succinate

    Headache, Fever, Sore Throat, minor Aches & Pains

    Sneezing, Runny Nose

    Cough

    2 BOTTLES - 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)

    309

  • INGREDIENTS AND APPEARANCE
    VICKS DAYQUIL AND VICKS NYQUIL  ELDERBERRY COLD AND FLU
    acetaminophen, dextromethorphan hbr, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84126-309
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84126-309-241 in 1 PACKAGE; Type 0: Not a Combination Product07/09/2024
    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  ELDERBERRY COLD AND FLU
    acetaminophen, dextromethorphan hbr liquid
    Product Information
    Item Code (Source)NDC:84126-307
    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
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84126-307-12354 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 DrugM01207/09/2024
    Part 2 of 2
    VICKS NYQUIL  ELDERBERRY COLD AND FLU
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Item Code (Source)NDC:84126-308
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    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 BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84126-308-12354 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 DrugM01207/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/09/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novacyl Wuxi Pharmaceutical Co., Ltd.263624659api manufacture(84126-308)