Label: UP AND UP COLD FLU RELIEF DAY NIGHT- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 December 13, 2019

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  • Active ingredients - Nighttime (in each 30 mL dose cup)

    Acetaminophen 650 mg

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Active ingredients - Daytime (in each 15 mL tablespoon)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purpose - Nighttime

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Purpose - Daytime

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses - Nighttime

    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

    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 - Nighttime

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. 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

    Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • Warnings - Daytime

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours. 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, which is the maximum daily amount
    •
    taken with other drugs containing acetaminophen
    •
    adult has 3 or more alcoholic drinks every day while using this product

    Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use - Nighttime

    •
    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.
    •
    to make a child sleepy
    •
    if you have ever had an allergic reaction to this product or any of its ingredients

    Do not use - Daytime

    •
    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
    •
    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
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    glaucoma
    •
    a sodium-restricted diet

    Ask a doctor before use if you have - Daytime

    •
    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 as occurs with smoking, asthma, 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

    •
    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

    •
    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

    •
    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.

    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 Liver warning
    •
    use dose cup
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL (2 TBSP) every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
    •
    when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
  • Directions - Daytime

    •
    take only as directed – see Liver warning
    •
    use dose cup
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL (2 TBSP) every 4 hrs

    children 6 to under 12 yrs

    15 mL (1 TBSP) every 4 hrs

    children 4 to under 6 yrs

    ask a doctor

    children under 4 yrs

    do not use
    •
    when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
  • Other information - Nighttime

    •
    each 30 mL dose cup contains: sodium 39 mg
    •
    store at 20-25°C (68-77°F)
  • Other information - Daytime

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

    alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Inactive Ingredients - Daytime

    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?

    Call 1-800-910-6874

  • Principal Display Panel - Daytime

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

    cold/flu relief

    multi-symptom

    day / non-drowsy

    pain reliever/fever reducer, cough suppressant, nasal decongestant

    acetaminophen – aches/fever

    dextromethorphan HBr – cough

    phenylephrine HCl – nasal congestion

    alcohol free, antihistamine free

    DAY

    original flavor

  • Principal Display Panel - Nighttime

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

    cold/flu relief

    multi-symptom

    night

    antihistamine, cough suppressant, fever reducer/pain reliever

    acetaminophen – aches/fever/sore throat

    dextromethorphan HBr – cough

    doxylamine succinate – sneezing, runny nose

    does not contain pseudoephedrine

    ALCOHOL 10%

    NIGHT

    cherry flavor

    TWO – 12 FL OZ (355 mL), TOTAL 24 FL OZ (1.5 pt) (710 mL)

    Up and Up Cold/Flu Relief Day Night Image 1
    Up & Up Cold/Flu Relief Day Night Image 2
    Up & Up Cold/Flu Relief Day Night Image 3
  • INGREDIENTS AND APPEARANCE
    UP AND UP COLD FLU RELIEF DAY NIGHT 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-733
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-733-021 in 1 CARTON; Type 0: Not a Combination Product08/18/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 355 mL
    Part 21 BOTTLE 355 mL
    Part 1 of 2
    UP AND UP COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate suspension
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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
    ColorRED (Clear/Dark Red) Score    
    ShapeSize
    FlavorCHERRY (Menthol Aroma) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    1355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/22/2011
    Part 2 of 2
    UP AND UP COLD FLU RELIEF 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl suspension
    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, ANHYDROUS (UNII: KH7I04HPUU)  
    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
    11 in 1 CARTON
    1355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/07/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/18/2014
    Labeler - Target Corporation (006961700)
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