GOOD SENSE NIGHTTIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [L. PERRIGO COMPANY]

GOOD SENSE NIGHTTIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [L. PERRIGO COMPANY]
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NDC 0113-0567-02
Set ID 54d894ff-2db5-4a85-8477-53dffbcd5981
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • Nighttime Cold & Flu Active Ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • 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
  • 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
    glaucoma
    cough that occurs with too much phlegm (mucus)
    a breathing problem such as emphysema or chronic bronchitis
    trouble urinating due to an enlarged prostate gland
    persistent or chronic cough as occurs with smoking, asthma, or emphysema
    a sodium-restricted diet
  • Ask a doctor or pharmacist before use if you are

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

    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

    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.
  • 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

    take only as directed – see Overdose warning
    only use the dose cup provided
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • Other information

    each 30 mL contains: sodium 38 mg
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or comments?

    1-800-719-9260

  • Daytime Cold & FluActive ingredients (in each 15 mL)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:
    cough due to minor throat and bronchial irritation
    sore throat
    headache
    minor aches and pains
    fever
    nasal congestion
  • Warnings

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

    adult takes more than 4,000 mg of acetaminophen in 24 hours
    child takes more than 5 doses in 24 hours
    taken with other drugs containing acetaminophen
    adult has 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
    heart disease
    thyroid disease
    diabetes
    high blood pressure
    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, or emphysema
  • 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 5 days (children) or 7 days (adults)
    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

    take only as directed – see Overdose warning
    only use the dose cup provided
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 4 hrs

    children 6 to under 12 yrs

    15 mL every 4 hrs

    children 4 to under 6 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • Other information

    each 15 mL contains: sodium 7 mg
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Multi-Symptom Relief

    Non-Drowsy

    See New Warnings

    Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

    DayTime

    Cold & Flu

    Acetaminophen

    Phenylephrine HCl

    Dextromethorphan HBr

    Aches

    Fever

    Cough

    Sore Throat

    Nasal Congestion

    Compare to active ingredients of Vicks® DayQuil® Cold & Flu

    12 FL OZ (354 mL)

    Alcohol Free

    Powerful

    Non-Drowsy Relief

    Multi-Symptom Relief

    See New Warnings

    Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

    NightTime

    Cold & Flu

    Acetaminophen

    Dextromethorphan HBr

    Doxylamine Succinate

    Aches

    Fever

    Cough

    Sore Throat

    Sneezing - Runny Nose

    Original Flavor

    Compare to active ingredients of Vicks® NyQuil® Cold & Flu

    12 FL OZ (354 mL)

    ALCOHOL 10%

    GoodSense DayTime NightTime Cold & Flu image 1
    GoodSense DayTime NightTime Cold & Flu image 2
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE NIGHTTIME DAYTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0567
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0567-021 in 1 KIT; Type 0: Not a Combination Product01/03/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 354 mL
    Part 21 BOTTLE 354 mL
    Part 1 of 2
    GOOD SENSE NIGHT TIME 
    acetaminophen, dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorGREEN (clear, bright green) Score    
    ShapeSize
    FlavorFRUIT (anise / cooling menthol aroma) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/19/2011
    Part 2 of 2
    GOOD SENSE DAYTIME  NON DROWSY COLD AND FLU
    acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHOL (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorORANGE (clear) Score    
    ShapeSize
    FlavorMENTHOL (with fruit) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/25/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/03/2014
    Labeler - L. Perrigo Company (006013346)

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