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

  • NDC Code(s): 63941-344-08, 63941-344-12
  • Packager: Best Choice (Valu Merchandisers Company)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 21, 2024

If you are a consumer or patient 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 common cold/flu symptoms
      • minor aches and pains
      • headache
      • sore throat
      • fever
      • 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

    • 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.
    • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

    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 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-hours 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: do not 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 19 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6,, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    *Compare to the active ingredients in Vicks® NyQuil® Cold & Flu

    Cold & Flu Relief

    ACETAMINOPHEN 650 mg, PAIN RELIEVER / FEVER REDUCER

    DEXTROMETHORPHAN HBr 30 mg, COUGH SUPPRESSANT 

    DOXYLAMINE SUCCINATE 12.5 mg, ANTIHISTAMINE

    For relief of:

    • Cough
    • Sneezing & runny nose
    • Headache, fever & sore throat
    • Minor aches & pains

    FOR AGES 12 YEARS AND OVER

    NIGHTTIME

    ALCOHOL 10%

    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 CAP IS BROKEN OR MISSING.

    PROUDLY DISTRIBUTED BY:

    ASSOCIATED WHOLESALE GROCERS, INC.

    KANSAS CITY, KANSAS 66106

  • Product Label

    Acetaminophen 650 Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

    BEST CHOICE Nighttime Cold and Flu Relief

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  NIGHTTIME
    acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-344
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-344-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/2016
    2NDC:63941-344-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/31/2016
    Labeler - Best Choice (Valu Merchandisers Company) (868703513)