NIGHT-TIME ORIGINAL MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]

NIGHT-TIME ORIGINAL MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-144-00, 68016-144-01
Set ID fc39b8dd-a4bd-4b40-accf-edd248a0b4fa
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number PART343
  • Active ingredients

    Drug Facts

    Active ingredients (in each 30 mL dose cup)


    Acetaminophen 650 mg   

    Dextromethorphan HBr 30 mg   

    Doxylamine Succinate 12.5 mg

  • Purpose

    Pain reliever/fever reducer   
    Cough suppressant   
    Antihistamine  

  • Keep out of reach of children

    Keep out of reach of children.

  • Uses

    temporarily relieves cold/flu symptoms:

    • sore throat
    • headache   
    • minor aches and pain
    • fever
    • runny nose and sneezing
    • cough due to minor sore throat and bronchial irritation

     

  • Warnings

    Failure to follow these warnings could result in serious consequences

    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 *with other drugs containing acetaminophen *3 or more alcoholic drinks every day while using this product.

    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
    • to make a child sleepy
  • 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 a doctor or pharmacist before use

    • if you are taking sedatives or tranquilizers
    • if you are taking the blood thinning drug warfarin
  • 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 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, headache that lasts


    • These could be signs of a serious condition.
  • If pregnant or breast-feeding

    ask a health professional before use.

  • 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.

  • Directions

    • take only as recommended-see Overdose warnings
    • Use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours
    • If taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours
    AptaPharma NightTimeMSC Flu2 Label
  • Other information

    • each 30 mL dose cup contains:
    • sodium 45 mg
    • store at room temperature
  • Inactive ingredients

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

  • Questions?

    Call weekdays

    1-877-798-5944

  • Product Label

    NDC 68016-144-01
    COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®

    Premier Value®

    Original

    Night-Time
    MULTI-SYMPTOM COLD/FLU RELIEF

    Acetaminophen……Pain Reliever/Fever Reducer
    Dextromethorphan HBr……Cough Suppressant
    Doxylamine Succinate ……………Antihistamine

    12 FL OZ (354 mL)
    INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    *This product is not manufactured or distributed by Procter and 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
    CHAN DRUG CONSORTIUM
    3301 NW BOCO RATON BLVD
    SUITE 101, BOCA RATON FL 33431
    LR-024

    AptaPharma NightTimeMSC Flu1 Label

  • INGREDIENTS AND APPEARANCE
    NIGHT-TIME ORIGINAL  MULTI-SYMPTOM COLD/FLU RELIEF
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-144
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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 400 (UNII: B697894SGQ)  
    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:68016-144-00236 mL in 1 BOTTLE
    2NDC:68016-144-01354 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/01/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-144)

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