Label: UP AND UP COLD RELIEF- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, 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 October 25, 2012

If you are a consumer or patient please visit this version.

  • Active ingredients (in each caplet) Cold Multi-Symptom Day

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Active ingredients (in each caplet) Cold Multi-Symptom Night

    Acetaminophen 325 mg

    Chlorpheniramine maleate 2 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purpose (Day)

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Purpose (Night)

    Pain reliever/fever reducer

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • Uses (Day)

    temporarily relieves these common cold/flu symptoms:
    minor aches and pains
    headache
    sore throat
    nasal congestion
    cough
    sinus congestion and pressure
    helps clear nasal passages
    promotes nasal and sinus drainage
    temporarily reduces fever
  • Uses (Night)

    temporarily relieves these common cold/flu symptoms:
    minor aches and pains
    headache
    sore throat
    nasal congestion
    cough
    sneezing and runny nose
    sinus congestion and pressure
    helps clear nasal passages
    relieves cough to help you sleep
    temporarily reduces fever
  • Warnings

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

    more than 12 caplets in 24 hours, which is the maximum daily amount
    with other drugs containing acetaminophen
    3 or more alcoholic drinks every day while using this product

    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.
    to make a child sleepy

    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
    cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    cough that occurs with too much phlegm (mucus)
    a breathing problem such as emphysema or chronic bronchitis
    glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers
    taking the blood thinning drug warfarin

    When using these products

    do not exceed recommended dosage

    In addition, when using Cold Multi-Symptom Night:

    excitability may occur, especially in children
    marked drowsiness may occur
    alcohol, sedatives and tranquilizers may increase drowsiness
    avoid alcoholic drinks
    be careful when driving a motor vehicle or operating machinery

    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.

    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

    do not take more than directed (see Liver warning)
    do not take the Day and Night caplets at the same time
    do not take more than a total of 12 caplets in 24 hours

    DAYTIME

    adults and children 12 years and over

    take 2 caplets every 4 hours
    swallow whole – do not crush, chew or dissolve

    children under 12 years

    do not use this adult product in children under

    12 years of age

    NIGHTTIME

    adults and children 12 years and over

    take 2 caplets every 4-6 hours
    swallow whole – do not crush, chew or dissolve

    children under 12 years

    do not use this adult product in children under

    12 years of age

  • Inactive ingredients

    DAYTIME acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide

    NIGHTTIME acesulfame potassium, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions?

    Call 1-800-910-6874

  • Principal Display Panel

    cold relief

    multi-symptom

    instant cooling sensation

    day/night combo pack

    pain reliever/fever reducer, nasal decongestant, cough suppressant, antihistamine*

    see new warnings information

    Compare to active ingredients in Tylenol® Cold Multi-Symptom Day

    acetaminophen - fever/headache/sore throat

    phenylephrine HCl - nasal congestion

    dextromethorphan HBr - coughing

    non-drowsy

    does not contain pseudoephedrine

    Compare to active ingredients in Tylenol® Cold Multi-Symptom Night

    acetaminophen - fever/headache/sore throat

    phenylephrine HCl - nasal congestion

    dextromethorphan HBr - coughing

    chlorpheniramine maleate - runny nose

    does not contain pseudoephedrine

    *antihistamine in nighttime only

    DAY/NIGHT

    20 COOL ICE® CAPLETS

    12 DAY (TOP) AND 8 NIGHT (BOTTOM)

    SHOWN ACTUAL SIZE ABOVE

    Cold Relief Carton Image 1
    Cold Relief Carton Image 2
    Cold Relief Carton Image 3
  • INGREDIENTS AND APPEARANCE
    UP AND UP COLD RELIEF 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-250
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-250-561 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK
    Part 21 BLISTER PACK 12 
    Part 1 of 2
    NIGHT 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, 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
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONES (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (light blue) Scoreno score
    ShapeCAPSULESize17mm
    FlavorVANILLA (menthol) Imprint Code L393
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/31/2009
    Part 2 of 2
    DAY 
    acetaminophen, dextromethorphan hbr, 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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONES (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize16mm
    FlavorVANILLA (menthol) Imprint Code L402
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/31/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/31/2009
    Labeler - Target Corporation (006961700)