Label: VICKS NYQUIL COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

  • NDC Code(s): 69423-995-02, 69423-995-08, 69423-995-16, 69423-995-24, view more
    69423-995-48
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 3, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each LiquiCap)

    Acetaminophen 325 mg
    Dextromethorphan HBr 15 mg
    Doxylamine succinate 6.25 mg

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
    • runny nose & sneezing
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    • more than 8 LiquiCaps 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
    • 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

    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, & tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • pain 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.

    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 8 LiquiCaps per 24 hrs
    adults & children 12 yrs & over2 LiquiCaps with water every 6 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use
  • Other information

    • store at no greater than 25°C
  • Inactive ingredients

    D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: This package is safety-sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

  • SPL UNCLASSIFIED SECTION

    Made in Canada

    DIST. BY:
    PROCTER & GAMBLE,
    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL

    VICKS®

    NyQuil®

    COLD & FLU

    Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

    • Headache, Fever, Sore Throat, Minor Aches & Pains
    • Sneezing, Runny Nose
    • Cough

    Nighttime Relief

    16 LiquiCaps ®

    557

  • INGREDIENTS AND APPEARANCE
    VICKS NYQUIL  COLD AND FLU
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-995
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code NQUIL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-995-022 in 1 POUCH; Type 0: Not a Combination Product01/01/2021
    2NDC:69423-995-168 in 1 CARTON01/01/2021
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69423-995-4824 in 1 CARTON01/01/2021
    32 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:69423-995-084 in 1 CARTON01/01/2021
    42 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:69423-995-248 in 1 CARTON01/01/2021
    53 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)