VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]

VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 37000-555-08, 37000-555-12, 37000-555-24
Set ID cd71be9f-4013-4ecd-9fcd-2bd3ffb7cf08
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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)