DAYTIME NITETIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]

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  • DAYTIME NITETIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]

DAYTIME NITETIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]
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NDC 30142-051-90
Set ID bac430ac-0db3-4218-ba9a-accf842f8e90
Category HUMAN OTC DRUG LABEL
Packager Kroger Company
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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  • Active ingredients (in each caplet) - Nighttime

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

  • Active ingredients (in each caplet) - Daytime

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purpose - Nighttime

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Purpose - Daytime

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses - Nighttime

    •
    temporarily relieves common cold/flu symptoms:
    •
    nasal congestion
    •
    sinus congestion and pressure
    •
    cough due to minor throat and bronchial irritation
    •
    cough to help you sleep
    •
    minor aches and pains
    •
    headache
    •
    fever
    •
    sore throat
    •
    runny nose and sneezing
    •
    reduces swelling of nasal passages
    •
    temporarily restores freer breathing through the nose
    •
    promotes nasal and/or sinus drainage
  • Uses - Daytime

    •
    temporarily relieves common cold/flu symptoms:
    •
    nasal congestion
    •
    sinus congestion and pressure
    •
    cough due to minor throat and bronchial irritation
    •
    minor aches and pains
    •
    headache
    •
    fever
    •
    sore throat
    •
    reduces swelling of nasal passages
    •
    temporarily restores freer breathing through the nose
    •
    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 - Nighttime

    •
    liver disease
    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    glaucoma
    •
    cough that occurs with too much phlegm (mucus)
    •
    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 before use if you have - Daytime

    •
    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
  • Ask a doctor or pharmacist before use if you are - Nighttime

    •
    taking sedatives or tranquilizers
    •
    taking the blood thinning drug warfarin
  • Ask a doctor or pharmacist before use if you are - Daytime

    taking the blood thinning drug warfarin

  • When using this product - Nighttime

    •
    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
  • When using this product - Daytime

    do not use more than directed

  • Stop use and ask a doctor if - Nighttime

    •
    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.
  • Stop use and ask a doctor if - Daytime

    •
    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.

    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 – Nighttime and Daytime

    •
    take only as directed - see overdose warning
    •
    do not exceed 4 doses 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 - Nighttime

    •
    store at 20-25°C (68-77°F)
  • Other information - Daytime

    •
    each caplet contains: sodium 4 mg
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients - Nighttime

    crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

  • Inactive ingredients - Daytime

    croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

  • Questions or comments?

     1-800-632-6900

  • Package/Label Principal Display Panel - Daytime

     COMPARE TO the active ingredients of VICKS® DAYQUIL® SEVERE

    See side panel

    NON-Drowsy

    DayTime

    Severe Cold & Flu

    Acetaminophen, Phenylephrine HCl,

    Dextromethorphan HBr, Guaifenesin

    Pain Reliever/Fever Reducer,

    Nasal Decongestant,

    Cough Suppressant, Expectorant

    MAXIMUM STRENGTH RELIEF

    Headache, Fever, Sore Throat, Minor Aches & Pains

    Nasal/Sinus Congestion & Sinus Pressure

    Cough

    Chest Congestion

    Our Pharmacists Recommend

    16 DAYTIME SEVERE CAPLETS

    actual size

    COMPARE TO the active ingredients of VICKS® NYQUIL® SEVERE

    See side panel

    NiteTime

    Severe Cold & Flu

    Acetaminophen, Phenylephrine HCl,

    Doxylamine Succinate, Dextromethorphan HBr

    Pain Reliever, Fever Reducer,

    Cough Suppressant, Antihistamine

    Nasal Decongestant

    MAXIMUM STRENGTH RELIEF

    Our Pharmacists Recommend

    8 NIGHTTIME SEVERE CAPLETS

    actual size

    1Y745-daytime-nitetime-image1.jpg
    1Y745-daytime-nitetime-image2.jpg
  • INGREDIENTS AND APPEARANCE
    DAYTIME NITETIME SEVERE 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-051
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-051-9024 in 1 CARTON05/24/2017
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 18 BLISTER PACK 8 
    Part 22 BLISTER PACK 16 
    Part 1 of 2
    NITETIME SEVERE 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated
    Product Information
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code L5Y5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/24/2017
    Part 2 of 2
    DAYTIME SEVERE 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
    Product Information
    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)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L922
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 CARTON
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/24/2017
    Labeler - Kroger Company (006999528)
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