Label: DAYTIME AND NITETIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit

  • NDC Code(s): 51013-124-02
  • Packager: PuraCap Pharmaceutical 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 10, 2019

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  • Active ingredients (in each softgel)

    Active ingredients for DayTime (in each Softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

    Active ingredients for NiteTime (in each Softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

  • Purpose

    DayTime Liquid Capsules

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

    NiteTime Liquid Capsules

    Pain reliever/fever reducer

    Cough suppressant 

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    • nasal congestion (DayTime only)
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing (NiteTime only)
  • Warnings

    Liver warning

    These products contain 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 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

    • 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 (NiteTime only)    

    Ask a doctor before use if you have

    • liver disease
    • heart disease (DayTime only)
    • thyroid disease (DayTime only)
    • diabetes (DayTime only)
    • high blood pressure (DayTime only)
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with excessive phlegm (mucus)    
    • persistent or chronic cough as occurs with smoking, asthma, or emphysema, and (for NiteTime only) chronic bronchitis
    • glaucoma (NiteTime only)

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (NiteTime only) 

    When using this product

    When using this product, do not use more than directed.

    In addition, when using NiteTime:

    • 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

    • you get nervous, dizzy, or sleepless (DayTime only)
    • pain, cough and (for DayTime only) nasal congestion gets worse or last more than 7 days
    • redness or swelling is present
    • 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.

    Keep out of reach of children.

    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 directed - see Overdose warning
    • swallow whole; do not crush, chew, or dissolve
    • do not exceed 4 doses per 24 hours                                                                                              
    Age DayTimeNiteTime
     adults and children 12 years of age and over take 2 softgels with water every 4 hours take 2 softgels with water every 6 hours
     children 4 to under 12 years of age ask a doctor ask a doctor
     children under 4 years of agedo not usedo not use

    When using other DayTime or NiteTime products, carefully read each label to ensure correct dosing

  • Other information

    • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • Inactive ingredients

    NiteTime: D&C yellow # 10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special and white edible ink 

    DayTime: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special and white edible ink

  • Questions or comments?

    Call toll free: 1-855-215-8180

  • Principal Display Panel

    ASSURED DayTime and NiteTime Liquid Capsules

    Combo Pack 12 count

    NDC 51013-124-02

    *Compare to the active ingredients in VICKS® DayQuil® and NyQuil® Cold and Flu LiquiCaps®

    Carton Label

  • INGREDIENTS AND APPEARANCE
    DAYTIME AND NITETIME 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-124
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-124-021 in 1 CARTON; Type 0: Not a Combination Product06/27/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 8 
    Part 21 BLISTER PACK 4 
    Part 1 of 2
    DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colororange (clear) Scoreno score
    Shapecapsule (oblong) Size20mm
    FlavorImprint Code PC9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/27/2016
    Part 2 of 2
    NITETIME 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorgreen (clear) Scoreno score
    Shapecapsule (oblong) Size20mm
    FlavorImprint Code PC10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/27/2016
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(51013-124) , analysis(51013-124)
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