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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 19, 2024

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Daytime Cold & Flu
    Active ingredients (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg

    Nighttime Cold & Flu
    Active ingredients (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 15 mg
    Doxylamine succinate 6.25 mg

  • PURPOSE

    Daytime Cold & Flu
    Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

    Nighttime Cold & Flu
    Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine

  • INDICATIONS & USAGE

    Uses
    temporarily relieves common cold/flu symptoms:

    • nasal congestion (Daytime only)
    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing (Nighttime only)
  • WARNINGS

    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
    • wilh 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

    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.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • liver disease
    • heart disease (Daytime only)
    • high blood pressure (Daytime only)
    • thyroid disease (Daytime only)
    • diabetes (Daytime only)
    • 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 (Daytime only)
    • glaucoma (Nighttime only)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis or emphysema (Nighttime only)

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Nighttime only)
  • WHEN USING

    When using this product

    • do not use more than directed (Daytime only)
    • excitability may occur, especially in children (Nighttime only)
    • marked drowsiness may occur (Nighttime only)
    • avoid alcoholic drinks (Nighttime only)
    • be careful when driving a motor vehicle or operating machinery (Nighttime only)
    • alcohol, sedatives, & tranquilizers may increase drowsiness (Nighttime only)
  • STOP USE

    Stop use and ask a doctor If

    • you get nervous, dizzy or sleepless (Daytime only)
    • pain, nasal congestion or cough get worse or last more than 7days (Daytime only)
    • 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.
    • pain, or cough gets worse or lasts more than 7days (Nighttime only)
    • These could be signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center righl away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • take only as directed
    • do not exceed 4 doses per 24 hrs

    adults & children 12yrs & over: 2 softgels with water every 6 hrs(Nighttime only)
    2 softgels with water every 4 hrs (Daytime only)
    children 4 to under 12 yrs: ask a doctor
    children under 4 yrs: do not use

  • OTHER INFORMATION

    Other information

    • store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients (Daytime only)
    FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
    Inactive ingredients (Nighttime only)
    FD&C blue #1, FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

  • QUESTIONS

    Questions? Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    day-night-24s-ifc

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl and acetaminophen, dextromethorphan hbr, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0729
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0729-242 in 1 CARTON10/15/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 1 of 2
    DAYTIME COLD AND FLU 
    acetaminophine dextromethorphan hbr phenylphrine hcl capsule, liquid filled
    Product Information
    Item Code (Source)NDC:0363-0853
    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)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SHELLAC (UNII: 46N107B71O)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVAL (Oblong shaped) Size21mm
    FlavorImprint Code 70
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/15/2021
    Part 2 of 2
    NIGHTTIME COLD AND FLU 
    acetaminophen dextromethorphan hbr doxylamine succinate capsule, liquid filled
    Product Information
    Item Code (Source)NDC:0363-0850
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN (UNII: 6O92ICV9RU)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVAL (Oblong shaped) Size21mm
    FlavorImprint Code 71
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/15/2021
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(0363-0729)