Label: COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate kit

  • NDC Code(s): 68016-879-48
  • Packager: Chain Drug Consortium, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2024

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

  • Drug Facts - Day Time

    Active ingredients (in each capsule)

    Acetaminophen USP 325 mg
    Dextromethorphan HBr USP 10 mg
    Phenylephrine HCl USP 5 mg

  • Drug Facts - Night Time

    Active ingredients (in each capsule)

    Acetaminophen USP 325 mg
    Dextromethorphan HBr USP 15 mg
    Doxylamine succinate USP 6.25 mg

  • Purpose - Day Time

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

  • Purpose - Night Time

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine



  • Uses - Day Time

    temporarily relieves common cold/flu symptoms:

      • nasal congestion
      • cough due to minor throat & bronchial irritation
      • sore throat
      • headache
      • minor aches & pains
      • fever
  • Uses - Night Time

    temporarily relieves common cold/flu symptoms:

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

  • Warnings - Day Time

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

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

  • Warnings - Night Time

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

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

  • Do not use - Day Time

    • 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.
  • Do not use - Night Time

    • 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 sleep
  • Ask a doctor before use if you have - Day Time


    • liver disease

    • heart disease

    • thyroid disease

    • diabetes

    • high blood pressure

    • trouble urinating due to enlarged prostate gland

    • cough that occurs with too much phlegm (mucus)

    • persistent or chronic cough as occurs with smoking, asthma, or emphysema

  • Ask a doctor before use if you have - Night Time

    • 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 - Day Time

    taking the blood thinning drug warfarin

  • Ask a doctor or pharmacist before use if you are - Night Time

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin
  • When using this product,

    do not use more than directed.

  • When using this product - Night Time

    • 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 - Day Time

    • you get nervous, dizzy or sleepless

    • symptoms get worse or last more than 5 days (children) or 7 days (adults)

    • 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.

  • Stop use and ask a doctor if - Night Time

    • 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.

  • If pregnant or breast-feeding, - Night Time

    ask a health professional before use.

  • Keep out of reach of children. - Day Time

    Overdose warning:

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • Keep out of reach of children. - Night Time

    Overdose warning:

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • Directions - Day Time

    • take only as directed – see Overdose warning
    • do not exceed 4 doses per 24 hours

    adults & children 12 yrs & over
    2 capsules with water every 4 hrs
    children 4 to under 12 yrs
    ask a doctor
    children under 4 yrs
    do not use

    when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

  • Directions - Night Time

    • take only as directed – see Overdose warning
    • do not exceed 4 doses per 24 hours

    adults & children 12 yrs & over
    2 capsules with water every 6 hrs
    children 4 to under 12 yrs
    ask a doctor
    children under 4 yrs
    do not use

    when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

  • Other information - Day Time

    • store at room temperature
  • Other information - Night Time

    • store at room temperature
  • Inactive ingredients - Day Time

    citric acid anhydrous, gelatin, glycerin, Neelicert FD & C Red No. 40, Neelicert FD & C Yellow No. 6, noncrystallizing sorbitol solution, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, titanium dioxide

  • Inactive ingredients - Night Time

    D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    call 1-855-274-4122
     
    Distributed by:
    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, Pa 19087


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 16 FL OZ (474 mL Bottle)

    NDC 68016-879-18

    Premier Value
    ®


    COMPARE TO THE ACTIVE INGREDIENTS IN
    VICKS® DAYQUIL® AND VICKS® Nyquil® COLD &
    FLU MULTI-SYMPTOM RELIEF LIQUICAPS®

    Non-Drowsy                                                  Multi-Symptom
    Daytime                                                          Nighttime

                                        COLD & FLU RELIEF

    Acetaminophen,
                                                  Acetaminophen,
    Dextromethorphan HBr and                         Dextromethorphan HBr,
    Phenylephrine HCl Capsules                         Doxylamine Succinate Capsules
    325 mg/10 mg/5 mg                                         325 mg/15 mg/6.25 mg

         •  Aches, Fever & Sore Throat                  •  Aches, Fever & Sore Throat
         •   Nasal Congestion                                  •  Sneezing, Runny Nose
         •   Cough                                                   •  Cough

                                           32 Capsules               16 Capsules

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 48 Capsule Bottle

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF 
    acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-879
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-879-481 in 1 PACKAGE; Type 0: Not a Combination Product07/12/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 116 BLISTER PACK 32 
    Part 28 BLISTER PACK 16 
    Part 1 of 2
    DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (orange to reddish orange) Scoreno score
    ShapeOVALSize20mm
    FlavorImprint Code Q01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/12/2019
    Part 2 of 2
    NIGHTTIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code Q07
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/12/2019
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777MANUFACTURE(68016-879)