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

  • NDC Code(s): 11673-969-48, 11673-975-24, 11673-976-24
  • Packager: TARGET CORP
  • 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 July 8, 2020

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  • DAYTIME COLD AND FLU RELIEFDRUG FACTS

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredients (in each softgels)

    • Acetaminophen 325 mg
    • Dextromethorphan HBr 10 mg
    • Phenylephrine HCl 5 mg
  • INACTIVE INGREDIENT

    Inactive ingredients

    FD&C blue 1, FD&C Yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, purified water, sorbitol sorbitan solution, titanium dioxide

  • PURPOSE

    PURPOSE

    • Pain reliever/fever reducer
    • Cough suppressant
    • Nasal decongestant

  • INDICATIONS & USAGE

    Uses
    temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever

  • DOSAGE & ADMINISTRATION

    DIRECTIONS
    • take only as directed
    • do not exceed 4 doses per 24 hours
    adults & children 12 yrs & over2 Softgels with water every 6 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not 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 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.

  • WARNINGS

    Warnings
    Liver warning     - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8 softgels in 24 hrs, which is the maximum daily amount for this product

    Severe liver damage may occur if you take:

    • more than 8 softgels 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.

  • NIGHTIME DRUG FACTS

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)

    • Acetaminophen 325 mg
    • Dextromethorphan HBr 15 mg
    • Doxylamine succinate 6.25 mg
  • INACTIVE INGREDIENT

    FD&C red #40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, purified water, sorbitol sorbitan solution, titanium dioxide

  • PURPOSE

    temporarily relieves common cold/flu symptoms:

    nasal congestion
    cough due to minor throat & bronchial irritation
    sore throat
    headache
    minor aches & pains
    fever

  • INDICATIONS & USAGE

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

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
    • runny nose & sneezing
  • DOSAGE & ADMINISTRATION

    DIRECTION
    • take only as directed
    • do not exceed 4 doses
    adults & children 12 yrs & over2 Softgels with water every 4 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • WARNINGS

    Warnings
    Liver warning     - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8 softgels in 24 hrs, which is the maximum daily amount for this product ...

    Liver warning

    This product contains acetaminophen.Severe liver damage may occur if you take:

    • more than 8 softgels 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.

  • PRINCIPAL DISPLAY PANEL

    48 ct

  • INGREDIENTS AND APPEARANCE
    DAYTIME- NIGHTTIME COLD AND FLU 
    daytime nighttime cold and flu kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-969
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-969-481 in 1 BLISTER PACK; Type 0: Not a Combination Product07/08/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 24 
    Part 21 BLISTER PACK 24 
    Part 1 of 2
    DAYTIME COLD AND FLU MULTI SYMPTOM 
    daytime cold and flu multi symptom capsule, liquid filled
    Product Information
    Item Code (Source)NDC:11673-975
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    POVIDONE (UNII: FZ989GH94E)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code 70
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-975-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/08/2020
    Part 2 of 2
    NIGHTIME COLD AND FLU 
    nightime cold and flu capsule, liquid filled
    Product Information
    Item Code (Source)NDC:11673-976
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    SHELLAC (UNII: 46N107B71O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code 71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-976-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/08/2020
    Labeler - TARGET CORP (006961700)
    Registrant - TIME CAP LABS INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(11673-969)
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