Label: VICKS FLU THERAPY SEVERE COLD AND FLU NIGHT- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution

  • NDC Code(s): 37000-926-01
  • 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 February 12, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Acetaminophen 650 mg

    Diphenhydramine HCl 25 mg

    Phenylephrine HCl 10 mg

    Pain reliever/fever reducer

    Antihistamine/Cough suppressant

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    • minor aches & pains
    • sore throat
    • fever
    • headache
    • cough due to minor throat & bronchial irritation
    • cough to help you sleep
    • nasal congestion
    • sinus congestion & pressure
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • runny nose
    • sneezing
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 6 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
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • Do not use more than directed
    • excitability may occur especially in children
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • pain, nasal congestion, 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
    • do not exceed 6 doses per 24 hrs

    adults & children 12 yrs & over one packet every 4 hrs
    children under 12 yrs do not use

    • Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes
    • If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat
  • Other information

    • potassium 10 mg
    • phenylketonurics: contains phenylalanine 68 mg per dose
    • do not exceed 25°C.
  • Inactive ingredients

    acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE,
    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 6 packet backer card and insert

    VICKS ®



    NIGHT

    FLUTherapy

    Acetaminophen - Pain Reliever/Fever reducer, Diphenhydramine HCl-

    SEVERE COLD & FLU

    Antihistamine/Cough suppressant Phenylephrine HCl - Nasal decongestant

    Soothing Vapors +

    Relieves:

    • Nasal Congestion
    • Sore Throat
    • Body Aches
    • Fever
    • Runny Nose
    • Cough



    HoneyLemon Flavor



    6 PACKETS

    Night

  • INGREDIENTS AND APPEARANCE
    VICKS FLU THERAPY  SEVERE COLD AND FLU NIGHT
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-926
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 g
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 5 g
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SUCROSE (UNII: C151H8M554)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorHONEY (Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-926-016 in 1 BLISTER PACK04/17/2019
    15 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/17/2019
    Labeler - The Procter & Gamble Manufacturing Company (004238200)