Label: VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid

  • NDC Code(s): 37000-555-08, 37000-555-12
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 10, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 15 mL tablespoon)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
  • 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 adult/child takes

    • more than 4 doses 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

    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.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • trouble urinating due to enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough 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
    • symptoms 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

    Taking more than directed 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 & 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 4 hrs
    children 6 to under 12 yrs15 mL (1 TBSP) every 4 hrs
    children 4 to under 6 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 tablespoon contains: sodium 50 mg
    • store at room temperature
  • Inactive ingredients

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

  • Questions?

    1-800-251-3374
    www.vicks.com

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202.

  • PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

    50% MORE
    than our 8 oz size

    VICKS®

    DayQuil®

    COLD & FLU

    Multi-Symptom Relief

    Acetaminophen, Phenylephrine, Dextromethorphan

    • Aches, Fever & Sore Throat
    • Nasal Congestion
    • Cough

    Non-Drowsy
    Alcohol Free / Antihistamine Free

    12 FL OZ
    (354 ml)

    PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    VICKS DAYQUIL  COLD AND FLU MULTI-SYMPTOM RELIEF
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorAPRICOTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-555-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2011
    2NDC:37000-555-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/22/2011
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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