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

  • NDC Code(s): 81179-044-01, 81179-088-01, 81179-803-01
  • Packager: YET HEALTH GROUP LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 3, 2024

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  • NIGHTTIME COLD & FLU Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

  • DAYTIME COLD & FLU Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • NIGHTTIME COLD & FLU Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • DAYTIME COLD & FLU Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • NIGHTTIME COLD & FLU Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
  • DAYTIME COLD & FLU Uses

    Temporarily relieves common cold/flu symptoms:

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

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

    • more than 4 doses in 24 hours, 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
  • NIGHTTIME COLD & FLU Ask a doctor before use if you have

    • 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 emphasema
    • trouble urinating due to an enlarged prostate gland
  • DAYTIME COLD & FLU Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • NIGHTTIME COLD & FLU Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin
  • DAYTIME COLD & FLU Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

  • NIGHTTIME COLD & FLU When using this product

    • do not exceed recommended dosage
    • 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
  • DAYTIME COLD & FLU When using this product

    do not use more than directed.

  • NIGHTTIME COLD & FLU Stop use and ask a doctor if

    • 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.

  • DAYTIME COLD & FLU Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • pain, nasal congestion, 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.

  • If pregnant or breast-feeding,

    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.

  • NIGHTTIME COLD & FLU Directions

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

    adults & 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
  • DAYTIME COLD & FLU Directions

    take only as directed

    do not exceed 4 doses per 24 hrs

    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

  • Other information

    • store at room temperature
  • NIGHTTIME COLD & FLU Inactive ingredients

    D&C YELLOW #10, FD&C BLUE #1, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SORBITOL 70% SOLUTION, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

  • DAYTIME COLD & FLU Inactive ingredients

    FD&C RED #40, FD&C YELLOW #6, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

  • Questions or comments?

    CALL TOLL-FREE 1-844-735-0202

  • PRINCIPAL DISPLAY PANEL

    01b UC_B-B_Daytime-Nighttime Cold-Flu Relief_80-40

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81179-803
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81179-803-011 in 1 CARTON09/02/2021
    11 in 1 BOTTLE; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 40 
    Part 21 BOTTLE 80 
    Part 1 of 2
    NIGHTTIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
    Product Information
    Item Code (Source)NDC:81179-044
    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
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 1000000 (UNII: HZ58M6D839)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code IS2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81179-044-0140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/02/2021
    Part 2 of 2
    DAYTIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Item Code (Source)NDC:81179-088
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code IS1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81179-088-0180 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/02/2021
    Labeler - YET HEALTH GROUP LLC (117763296)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medgel Private Ltd677385498manufacture(81179-803)
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