DAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]

DAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]
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NDC 56062-580-72
Set ID af1bbd44-4c2b-424b-abbf-684c515cbec1
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • Active ingredients (in each softgel) – Nighttime Cold & Flu

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

  • Active ingredients (in each softgel) – Daytime Cold & Flu

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purpose – Nighttime Cold & Flu

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Purpose – Daytime Cold & Flu

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses – Nighttime Cold & Flu

    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
  • Uses – Daytime Cold & Flu

    temporarily relieves common cold/flu symptoms:

    nasal congestion
    cough due to minor throat and bronchial irritation
    sore throat
    headache
    minor aches and pains
    fever
  • 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, lasts 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 these products.
    if you have ever had an allergic reaction to these products or any of their ingredients

    Ask a doctor before use if you have – Nighttime Cold & Flu

    liver disease
    glaucoma
    cough that occurs with too much phlegm (mucus)
    a breathing problem such as emphysema or chronic bronchitis
    persistent or chronic cough as occurs with smoking, asthma, or emphysema
    trouble urinating due to an enlarged prostate gland

    Ask a doctor before use if you have – Daytime Cold & Flu

    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 as occurs with smoking, asthma, or emphysema

    Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu

    taking sedatives or tranquilizers
    taking the blood thinning drug warfarin

    Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu

    taking the blood thinning drug warfarin

    When using this product – Nighttime Cold & Flu

    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 the product – Daytime Cold & Flu

    do not use more than directed

    Stop use and ask a doctor if – Nighttime Cold & Flu

    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.

    Stop use and ask a doctor if – Daytime Cold & Flu

    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 Cold & Flu

    take only as directed – see overdose warning
    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

  • Directions – Daytime Cold & Flu

    take only as directed – see overdose warning
    do not exceed 4 doses per 24 hrs

    adults & 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

  • Other information

    store at 20-25°C (68-77°F)
  • Inactive ingredients – Nighttime Cold & Flu

    D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Inactive ingredients – Daytime Cold & Flu

    edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Principal Display Panel - Daytime

    See New Warning

    NON-DROWSY

    daytime PE

    ACETAMINOPHEN – ACHES, FEVER

    DEXTROMETHORPHAN HBr – COUGH

    PHENYLEPHRINE HCl – NASAL CONGESTION

    PAIN RELIEVER, FEVER REDUCER

    COUGH SUPPRESSANT

    NASAL DECONGESTANT

    MULTI-SYMPTOM

    COLD/FLU RELIEF

    Compare to Active Ingredients in Vicks® DayQuil®

    ACTUAL SIZE

    32 SOFTGELS

  • Principal Display Panel - Nighttime

    See New Warnings

    nitetime

    ACETAMINOPHEN – ACHES, FEVER

    DEXTROMETHORPHAN HBr – COUGH

    DOXYLAMINE SUCCINATE – SNEEZING, RUNNY NOSE

    PAIN RELIEVER, FEVER REDUCER

    COUGH SUPPRESSANT

    ANTIHISTAMINE

    MULTI-SYMPTOM

    COLD/FLU RELIEF

    Compare to Active Ingredients in Vicks® NyQuil®

    ACTUAL SIZE

    16 SOFTGELS

    daytime PE nitetime Carton Image 1
    daytime PE nitetime Carton Image 2
  • INGREDIENTS AND APPEARANCE
    DAYTIME PE NITETIME 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-580
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-580-721 in 1 CARTON; Type 0: Not a Combination Product07/07/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 18 BLISTER PACK 16 
    Part 216 BLISTER PACK 32 
    Part 1 of 2
    NITETIME 
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin 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 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 (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGREEN (clear) Scoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code 056
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/17/2014
    Part 2 of 2
    DAYTIME PE 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    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
    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 (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code L994
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/02/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/07/2014
    Labeler - Publix Super Markets Inc (006922009)

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