Label: UP AND UP DAYTIME SEVERE COLD NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, diphenhydramine hcl kit

  • 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 December 13, 2019

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  • Active ingredients (in each caplet) - DAY TIME Severe Cold

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Active ingredients (in each caplet) – NIGHT TIME Cold & Flu

    Acetaminophen 325 mg

    Diphenhydramine HCl 25 mg

    Phenylephrine HCl 5 mg

  • Purposes - DAY TIME Severe Cold

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Purposes - NIGHT TIME Cold & Flu

    Pain reliever/fever reducer

    Antihistamine

    Nasal decongestant

  • Uses

    •
    temporarily relieves these common cold and flu symptoms:
    •
    nasal congestion
    •
    cough (DAY TIME Severe Cold only)
    •
    minor aches and pains
    •
    headache
    •
    sore throat
    •
    runny nose and sneezing (NIGHT TIME Cold & Flu only)
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME Severe Cold only)
    •
    temporarily reduces fever
  • Warnings

    Liver warning: These products contain 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 these products

    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.
    •
    with any other product containing diphenhydramine, even one used on skin (NIGHT TIME Cold & Flu only)
    •
    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

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

    •
    taking the blood thinning drug warfarin
    •
    taking sedatives or tranquilizers (NIGHT TIME Cold & Flu only)
  • When using these products

    •
    do not use more than directed
    •
    excitability may occur, especially in children (NIGHT TIME Cold & Flu only)
    •
    marked drowsiness may occur (NIGHT TIME Cold & Flu only)
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME Cold & Flu only)
    •
    avoid alcoholic drinks (NIGHT TIME Cold & Flu only)
    •
    be careful when driving a motor vehicle or operating machinery (NIGHT TIME Cold & Flu only)
  • Stop use and ask a doctor if

    •
    nervousness, dizziness, or sleeplessness occur
    •
    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. (DAY TIME Severe Cold only)
  • 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

    •
    do not take more than directed (see Overdose warning)
    •
    do not take more than 10 caplets in any 24-hour period
    •
    adults and children 12 years of age and older: take 2 caplets every 4 hours
    •
    children under 12 years of age: do not use
  • Other information

    •
    each caplet contains: sodium 4 mg (DAY TIME Severe Cold only)
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients (DAY TIME Severe Cold)

    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

  • Inactive ingredients (NIGHT TIME Cold & Flu)

    crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

  • Questions?

    Call 1-888-547-7400

  • Principal Display Panel

    Compare to active ingredients in Mucinex® Fast-Max® Day Time Severe Cold

    see new warnings

    maximum strength

    daytime severe cold

    acetaminophen (pain reliever/fever reducer)

    dextromethorphan HBr (cough suppressant)

    guaifenesin (expectorant)

    phenylephrine HCl (nasal decongestant)

    relieves headache, fever and sore throat

    relieves nasal and chest congestion

    controls cough

    thins and loosens mucus

    ACTUAL SIZE

    AGES 12+ YEARS

    20 CAPLETS

    Compare to active ingredients in Mucinex® Fast-Max® Night Time Cold & Flu

    see new warnings

    maximum strength

    nighttime cold and flu

    acetaminophen (pain reliever/fever reducer)

    diphenhydramine HCl (antihistamine)

    phenylephrine HCL (nasal decongestant)

    relieves headache, fever and sore throat

    relieves nasal congestion

    relieves sneezing and runny nose

    ACTUAL SIZE

    AGES 12+ YEARS

    10 CAPLETS

    Up & Up daytime severe cold nighttime cold & flu image 1
    Up & Up daytime severe cold nighttime cold and flu image 2
    Up & Up daytime severe cold nighttime cold and flu image 3
  • INGREDIENTS AND APPEARANCE
    UP AND UP DAYTIME SEVERE COLD NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, diphenhydramine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-837
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-837-811 in 1 KIT; Type 0: Not a Combination Product03/25/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 BLISTER PACK 20 
    Part 25 BLISTER PACK 10 
    Part 1 of 2
    UP AND UP DAYTIME SEVERE COLD 
    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 (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code L922
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 PACKAGE
    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 finalpart34103/16/2015
    Part 2 of 2
    UP AND UP NIGHTTIME COLD AND FLU 
    acetaminophen, diphenhydramine hcl, 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
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 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 (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 PACKAGE
    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 finalpart341
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/25/2015
    Labeler - Target Corporation (006961700)
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