Label: DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

  • 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 April 12, 2022

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

  • ACTIVE INGREDIENT

    Active ingredients (in each Softgel) (Daytime)Purpose
    Acetaminophen 325mgPain Reliever/fever reducer
    Dextromethorphan HBr 10mgCough suppressant
    Phenylephrine HCl 5mgNasal Decongestant
    Active ingredients (in each Softgel) (Nighttime)Purpose
    Acetaminophen 325mgPain Reliever/fever reducer
    Dextromethorphan HBr 15mgCough suppressant
    Docylamine Succinate 6.25mgAntihistamine

  • PURPOSE

    Daytime

    Pain reliever/fever reducer, Cough suppresant and Nasal decongestant

    Nighttime

    Pain reliever/fever reducer, Cough suppressant and Antihistamine

  • INDICATIONS & USAGE

    * 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 (Nighttime only)

  • WARNINGS

    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 every day while using this product

    Allergy alert:
    Acetaminophen may cause severe skin reactions. Symptoms may include:
    *skin reddening
    *blisters
    *rash
    If a skin reaction occurs, stop use and seek medical help right away.

    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 sleep (Nighttime only).

    Ask a doctor before use if you have

    * liver disease
    * heart disease (Daytime only)
    * high blood pressure (Daytime only)
    * thyroid disease (Daytime only)
    * trouble urinating due to an enlarged prostate gland
    * glaucoma (Nighttime only)
    * persistent or chronic cough such as occurs with smoking, asthma or emphysema and (Nighttime only) chronic bronchitis
    * cough that occurs with too much phlegm (mucus)

    Ask a doctor or a pharmacist before use if you are
    * taking the blood thinning drug warfarin
    * taking sedatives or tranquilizers (Nighttime only)

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

    Stop use and ask a doctor if
    * you get nervous, dizzy, or sleepless (Daytime only)
    * pain, cough and nasal congestion (Daytime only) may get worse or lasts more than 7 days
    * new symptoms occur
    * fever gets worse or lasts more than 3 days
    * redness or swelling is present
    * 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 care professional before use.

    Keep out of reach of children

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    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.

  • DOSAGE & ADMINISTRATION

    Directions
    * take only as directed - see OVERDOSE WARNING

    * do not exceed 4 doses per 24 hrs
    * take softgels with water

    Read each label carefully before taking Daytime and Nighttime product

    DaytimeNighttime
    adulta & children age 12 years & over2 softgels every 4 hours2 softgels every 6 hours
    children 4 to under 12 yearsask a doctorask a doctor
    children under 4 yearsdo not usedo not use

  • OTHER SAFETY INFORMATION

    Other information
    * store at room temperature between 20 - 25°C (68 - 77°F)

    *avoid excessive heat, cold and humidity

  • INACTIVE INGREDIENT

    Inactive ingredients (Daytime)
    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.


    Inactive ingredients (Nightime)
    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

  • PRINCIPAL DISPLAY PANEL

    Daytime Nighttime Cold & Flu

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-602
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-602-121 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product11/06/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK
    Part 21 BLISTER PACK
    Part 1 of 2
    DAYTIME NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr , phenylephrine hcl capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 604
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart34111/06/2018
    Part 2 of 2
    DAYTIME NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 603
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart34111/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/06/2018
    Labeler - Strive Pharmaceuticals Inc. (080028013)