Label: DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit

  • NDC Code(s): 41250-569-00, 79481-0099-0, 79481-5200-0
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL

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 November 21, 2022

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  • Active ingredients (in each caplet) Daytime

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    •
    nasal congestion
    •
    sinus congestion and pressure
    •
    headache
    •
    cough due to minor throat and bronchial irritation
    •
    sore throat
    •
    minor aches and pains
    •
    reduces swelling of nasal passages
    •
    temporarily restores freer breathing through the nose
    •
    fever
    •
    promotes nasal and/or sinus drainage
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

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

    •
    more than 4,000 mg of acetaminophen in 24 hours
    •
    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
  • Ask a doctor before use if you have

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

    taking the blood thinning drug warfarin

  • When using this product

    do not use more than directed

  • 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
    •
    new symptoms occur
    •
    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 professional before use.

  • Keep out of reach of children.

    Overdose warning: 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 as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    take only as directed - see overdose warning
    •
    do not exceed 8 caplets per 24 hrs

    adults & children 12 yrs & over

    2 caplets with water every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    each caplet contains: sodium 3 mg
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Active ingredients (in each caplet) Nighttime

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    •
    nasal congestion
    •
    sinus congestion and pressure
    •
    headache
    •
    cough due to minor throat and bronchial irritation
    •
    sore throat
    •
    cough to help you sleep
    •
    minor aches and pains
    •
    fever
    •
    runny nose and sneezing
    •
    reduces swelling of nasal passages
    •
    temporarily restores freer breathing through the nose
    •
    promotes nasal and/or sinus drainage
  • Warnings

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

    •
    more than 4,000 mg of acetaminophen in 24 hours
    •
    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
  • Ask a doctor before use if you have

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

    •
    taking sedatives or tranquilizers
    •
    taking the blood thinning drug warfarin
  • When using this product

    •
    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, and tranquilizers may increase drowsiness
  • 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
    •
    new symptoms occur
    •
    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 professional before use.

  • Keep out of reach of children.

    Overdose warning: 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 as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    take only as directed - see overdose warning
    •
    do not exceed 8 caplets per 24 hrs

    adults & children 12 yrs & over

    2 caplets with water every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    COMBO PACK

    Compare to Vicks® DayQuil® Severe+VapoCOOL™active ingredients

    NON-DROWSY

    MAXIMUM STRENGTH

    vapor ice™

    daytime cold & flu

    Acetaminophen | Pain Reliever | Fever Reducer

    Phenylephrine HCl | Nasal Decongestant

    Dextromethorphan HBr | Cough Suppressant

    Guaifenesin | Expectorant

    SEVERE COLD & FLU

    Multi-Symptom

    32 Caplets

    actual size

    Compare to Vicks® NyQuil® Severe+VapoCOOL™ active ingredients

    MAXIMUM STRENGTH

    vapor ice™

    nighttime cold & flu

    Acetaminophen | Pain Reliever | Fever Reducer

    Phenylephrine HCl | Nasal Decongestant

    Doxylamine Succinate | Antihistamine

    Dextromethorphan HBr | Cough Suppressant

    SEVERE COLD & FLU

    Multi-Symptom

    16 Caplets

    actual size

    datime cold and flu nighttime cold and flu image 1
    daytime cold and flu nighttime cold and flu image 2
  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-5200
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-5200-01 in 1 CARTON; Type 0: Not a Combination Product08/21/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 116 BLISTER PACK 32 
    Part 28 BLISTER PACK 16 
    Part 1 of 2
    DAYTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated
    Product Information
    Item Code (Source)NDC:41250-569
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L35C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-569-002 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Part 2 of 2
    NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coated
    Product Information
    Item Code (Source)NDC:79481-0099
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L72V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0099-02 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/21/2021
    Labeler - Meijer Distribution Inc (006959555)
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