Label: DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK- daytime nighttime cold and flu kit

  • NDC Code(s): 69168-417-93, 69168-418-86, 69168-438-15
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 19, 2022

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

  • Active ingredient(s)

    DAYTIME ONLY

    Acetaminophen 325mg
    Dextromethorphan HBr 10mg
    Phenylephrine HCl 5mg

    NIGHTTIME ONLY

    Acetaminophen 325mg
    Dextromethorphan HBr 15mg
    Doxylamine succinate 6.25mg

  • Purpose

    DAYTIME ONLY

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

     

    NIGHTTIME ONLY

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine

  • Use(s)

    DAYTIME ONLY

    temporarily relieves common cold/flu symptoms: • nasal
    congestion • cough due to minor throat & bronchial irritation • sore
    throat • headache • minor aches & pains • fever

    NIGHTTIME ONLY

    temporarily relieves common cold/flu symptoms:
    • cough due to minor throat & bronchial irritation • sore throat • headache
    • minor aches & pains • fever • runny nose & sneezing

  • Warnings

    DAYTIME AND NIGHTTIME

    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,
    occurs with or is followed by fever, headache, rash, nausea, or vomiting,
    consult a doctor promptly.

    Do not use

    DAYTIME ONLY

    • 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.

    NIGHTTIME ONLY

    • 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

    DAYTIME ONLY

    • liver disease • heart disease • thyroid disease • diabetes • high blood pressure
    • trouble urinating due to an enlarged prostate gland • cough that occurs
    with too much phlegm (mucus) • persistent or chronic cough as occurs
    with smoking, asthma, or emphysema

    NIGHTTIME ONLY

    • 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

    DAYTIME ONLY

    taking the blood thinning drug warfarin.

     

    NIGHTTIME ONLY

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    DAYTIME ONLY

    do not use more than directed

     

    NIGHTTIME ONLY

    • 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

    DAYTIME ONLY

    • 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.

     

    NIGHTTIME ONLY

    • 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.

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center
    (1-800-222-1222) 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

    DAYTIME ONLY

    •  Take only as directed
    •  Do not exceed 4 doses in 24 hrs   

    adults and children 12 yrs & over: 2 softgels with water every 4 hrs

    children 4 to under 12 yrs: ask a doctor

    children under 4 yrs: do not use

     

    NIGHTTIME ONLY

    • Take only as directed
    •  Do not exceed 4 doses in 24 hrs 

    adults and children 12 yrs & over: 2 softgels with water every 6 hrs

    children 4 to under 12 yrs: ask a doctor

    children under 4 yrs: do not use


  • Other information

    • store at room temperature 20-25 °C (68-77° F)
    • do not use if blister unit is torn or open
  • Inactive ingredients

    DAYTIME ONLY

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene
    glycol, purified water, sorbitol sorbitan solution, white edible ink

     

    NIGHTTIME ONLY

    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene
    glycol, purified water, sorbitol sorbitan solution, white edible ink

  • Questions

    Questions or comments?
    Call 1-888-952-0050 Monday through Friday 9AM - 5PM

  • Principal Display Panel

    Day Time/Nighttime Cold and Flu

    Day Time/Nighttime Cold and Flu


  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK 
    daytime nighttime cold and flu kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-438
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-438-151 in 1 CARTON; Type 0: Not a Combination Product05/20/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 24 
    Part 21 BLISTER PACK 12 
    Part 1 of 2
    DAYTIME COLD AND FLU 
    acetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg capsule
    Product Information
    Item Code (Source)NDC:69168-417
    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 SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code PC9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-417-932 in 1 CARTON
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/20/2022
    Part 2 of 2
    NIGHTTIME COLD AND FLU RELIEF 
    acetaminophen capsule
    Product Information
    Item Code (Source)NDC:69168-418
    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 SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code PC10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-418-861 in 1 CARTON
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/20/2022
    Labeler - Allegiant Health (079501930)