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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 11, 2020

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 FINALpart34107/12/2019
    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 FINALpart34107/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/12/2019
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777MANUFACTURE(68016-879)