Label: COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

  • NDC Code(s): 63868-234-08, 63868-234-12
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 1, 2024

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

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Uses

    • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • fever
    • sore throat
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
  • Warnings

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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 an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking

    • sedatives or tranquilizers
    • the blood thinning drug warfarin

    When using this product

    • 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

    • pain or cough gets worse or lasts more than 7 days
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present 
    • 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

    • do not take more than directed (see overdose warning)
    • do not take more than 4 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device
    • mL= milliliter
    • keep dosing cup with product
    • adults and children 12 years and over: 30 mL every 6 hours
    • children under 12 years of age: donot use
    • When using other Day Time or Night Time products, carefully read each label to ensure correct dosing
  • Other information

    • each 30 mL contains: potassium 5 mg
    • each 30 mL contains: sodium 24 mg
    • Store between 20-25ºC (68-77º). Do not refrigerate.
  • Inactive ingredients

    acesulfame potassium, alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or comments?

    call 1-248-449-9300 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    *Compare to the active ingredients in VICKS® NYQUIL® Cold & Flu

    Nighttime

    Cold & Flu

    Acetaminophen

    Dextromethorphan HBr

    Doxylamine succinate

    For relief of:

    Aches | fever | Cough

    Runny Nose & Sneezing

    For Ages 12 Years & Over

    Nighttime Relief

    Alcohol 10%

    Cherry Flavor

    FL OZ (mL)

    *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAPIS BROKEN OR MISSING.

    Distributed by C.D.M.A., Inc.©

    43157 W.Nine Mile

    Novi. MI 48375

    www.qualitychoice.com

  • Product Label

    Acetaminophen 650 mg, Dextromethorphan HBr 30 mg, Doxylamine Succinate 12.5 mg

    QUALITY CHOICE Nighttime Cold & Flu

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  NIGHTTIME
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-234
    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 HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-234-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2016
    2NDC:63868-234-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/31/2016
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)