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Label: VICKS NYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution
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  • NDC Code(s): 37000-812-01, 37000-812-04, 37000-812-08, 37000-812-12, view more 37000-812-24, 37000-812-36
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 19, 2026

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

  • Download DRUG LABEL INFO: PDF XML
  • Official Label (Printer Friendly)
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each 30 mL)

    Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

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

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

    • more than 4 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 mor 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, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostate gland • a sodium-restricted diet

  • Ask a doctor or pharmacist before use if you are

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

  • When using this product

    • do not use more than directed • excitability may occur, especially in children

    • marked drowsiness 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

    • 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.
  • 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 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use
  • Other information

    • each 30 mL contains:sodium 92 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, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: Do not use if printed shrinkband is broken or missing.

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE

    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

    VICKS ®

    NyQuil™

    SEVERE

    COLD & FLU

    Acetaminophen, Phenylephrine HCI, Doxylamine Succinate, Dextromethorphan HBr

    Headache, Fever, Sore Throat, Minor Aches & Pains

    Nasal Congestion, Sinus Pressure

    Sneezing, Runny Nose

    Cough

    12 FL OZ (354 ml)

    Nighttime Relief

    812

  • INGREDIENTS AND APPEARANCE
    VICKS NYQUIL  SEVERE COLD AND FLU acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-812
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-812-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2013
    2NDC:37000-812-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2013
    3NDC:37000-812-242 in 1 PACKAGE07/22/2013
    3354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:37000-812-363 in 1 PACKAGE07/22/201307/10/2019
    4354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:37000-812-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    6NDC:37000-812-044 in 1 PACKAGE07/13/2021
    630 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 DrugM01207/22/2013
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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Safety

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Related Resources

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More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!

VICKS NYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution

Number of versions: 17

Published Date (What is this?) Version Files
Feb 23, 2026 17 (current) download
Oct 3, 2025 16 download
Oct 14, 2024 15 download
Jul 4, 2024 14 download
Oct 17, 2023 13 download
Aug 31, 2023 12 download
Aug 17, 2023 11 download
Aug 4, 2023 10 download
May 17, 2023 9 download
Feb 7, 2023 8 download
Oct 12, 2022 7 download
Jul 26, 2021 6 download
Feb 12, 2021 5 download
Jul 11, 2019 4 download
Dec 7, 2016 3 download
Oct 8, 2014 2 download
Jul 22, 2013 1 download

VICKS NYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution

RxCUI RxNorm NAME RxTTY
1 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution PSN
2 1431245 acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution SCD
3 1431245 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution SY
4 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution SY
5 1431245 APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution SY

VICKS NYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution

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VICKS NYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 37000-812-01
2 37000-812-04
3 37000-812-08
4 37000-812-12
5 37000-812-24
6 37000-812-36
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