Label: COLD AND FLU NIGHT TIME MULTI-SYMPTOM RELIEF ORIGINAL- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

  • NDC Code(s): 68016-239-08, 68016-239-12
  • Packager: Pharmacy Value Alliance, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredients (in each 30 mL dose cup)
    Acetaminophen                650 mg
    Dextromethorphan HBr      30mg
    Doxylamine Succinate     12.5 mg

  • PURPOSE

    Purpose
    Acetaminophen                 Pain reliever/fever reducer
    Dextromethorphan HBr     Cough suppressant
    Doxylamine Succinate       Antihistamine

  • INDICATIONS & USAGE

    Uses temporarily relieves cold/flu symptoms: • sore throat • headache
    • minor aches and pain • fever • runny nose and sneezing
    • cough due to minor throat and bronchial irritation

  • WARNINGS

    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, which is the maximum daily amount
    • 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 askin reaction occurs, stop use and seek medical help right away.

    Sore throat warning: If sore throat is severe, persists for more than
    two days, is accompanied or followed by fever, headache, rash,
    nausea, or vomiting, consult a doctor promptly.

  • DO NOT USE

    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.
    • to make a child sleepy

  • ASK DOCTOR

    Ask a doctor before use if you have
    • a sodium restricted diet • 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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use
    • if you are taking sedatives or tranquilizers
    • if you are taking the blood thinning drug warfarin

  • WHEN USING

    When using this product • do not use more than directed
    • avoid alcoholic drinks • excitability may occur, especially in children
    • marked drowsiness may occur
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

  • STOP USE

    Stop use and ask a doctor if • redness or swelling is present
    • symptoms do not get better within 7 days or are accompanied by a fever
    • fever gets worse or lasts more than 3 days • new symptoms occur
    • cough lasts more than 7 days, comes back, or occurs with fever, rash,
    or headache that lasts. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose warning: Taking more than the recommended dose can cause
    serious health problems. 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.

  • DOSAGE & ADMINISTRATION

    Directions • take only as recommended-see Overdose warning
    • Use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours

    adults and children 12              30 mL (2 TBSP)
    years and over                         every 6 hours

    children 4 to                             ask a doctor
    under 12 years                     

    children under 4years              do not use

    • If taking Night Time at night and Day Time during the day,
    limit total to 4 doses per 24 hours.

  • OTHER SAFETY INFORMATION

    Other information • each 30 mL dose cup contains:
    sodium 45 mg • store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients citric acid, D&C yellow # 10, FD&C
    Green No.3, FD&C Yellow No.6, flavor, glycerin,
    polyethylene glycol, propylene glycol, purified water,
    saccharin sodium, sodium benzoate, sodium citrate, sucrose

  • QUESTIONS

    QuestIons? Call weekdays from 9:30 am to 4:30 pm EST.
    1-877-798-5944.

  • Principal Display Panel

    Premier® Value

    COMPARE TO THE ACTIVE

    INGREDIENTS IN

    VICKS® NYQUIL®*

    Original Flavor

    COLD & FLU
    Night-time Multi-Symptom Relief

    Acetaminophen...... Pain Reliever/Fever Reducer
    Dextromethorphan Hbr...... Cough Suppressant
    Doxylamine Succinate........Antihistamine

    Non-drowsy

    8 FL OZ (237 mL)

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    Questions? Call weekdays 1-877-798-5944.
    *This product is not manufactured or distributed by Proctor &
    Gamble, owner of the registered trademark Vicks® NyQuil®.
    If for any reason you are not satisfied with this product, please
    return It to the store where purchased for a full refund.

    DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
    407 EAST LANCASTER AVENUE, WAYNE PA 19087

    LR-023

    REV-01

    Product label - 8 OZ Package

    NightTime 239-08

    Product label - 12 OZ Package

    239-12 12OZ

                                                      Premier® Value Cold & Flu Night-time Multi-Symptom Relief Original

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU NIGHT TIME MULTI-SYMPTOM RELIEF  ORIGINAL
    acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-239
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-239-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    2NDC:68016-239-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2018
    Labeler - Pharmacy Value Alliance, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-239)