Label: VICKS NYQUIL HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD AND FLU PLUS CONGESTION- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution

  • NDC Code(s): 58933-551-01, 58933-551-08
  • Packager: Procter & Gamble Manufactura S de RL de CV
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each Packet)

    Acetaminophen650 mg

    Diphenhydramine HCl 25 mg

    Phenylephrine HCl 10 mg

    Purpose

    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.

  • 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
  • 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.
    • with any other product containing diphenhydramine, even one used on the skin.
    • 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 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

    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

    • do not exceed 6 doses per 24 hrs

    • 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

    AgeDose
    Adults & children 12 yrs & overone packet (dose) every 4 hours
    Children under 12 yrsDo not use

  • Other information

    • each packet contains: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

    Tamper Evident: Do not use if sachet is opened or torn

    Keep outer package for complete product information.

  • SPL UNCLASSIFIED SECTION

    MADE IN MEXICO

    DIST. BY PROCTER & GAMBLE,

    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 8 packet package

    MAX STRENGTH

    Vicks® NyQuil™ HOT REMEDY

    RAPID RELIEF MULTI-SYMPTOM

    COLD & FLU + CONGESTION

    Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl

    Headache, Fever, Sore Throat, Minor Aches & Pains

    Sneezing, Runny Nose, Cough

    Nasal Congestion, Sinus Pressure

    Nighttime Relief

    HONEY LEMON FLAVORED

    8 POWDER PACKETS

    551

  • INGREDIENTS AND APPEARANCE
    VICKS NYQUIL HOT REMEDY RAPID RELIEF MULTI-SYMPTOM  COLD AND FLU PLUS CONGESTION
    acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58933-551
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 g
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 5 g
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 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:58933-551-015 g in 1 PACKET; Type 0: Not a Combination Product03/22/2023
    2NDC:58933-551-088 in 1 PACKAGE03/22/2023
    25 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/22/2023
    Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIVI'S LABORATORIES LIMITED676446492api manufacture(58933-551)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kongo Chemical Co., Ltd.690908686api manufacture(58933-551)
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