Label: COLD MEDICINE XL3- acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet

  • 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 October 20, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients (in each capsule)
    Acetaminophen 325 mg
    Chlorpheniramine Maleate 4 mg
    Phenylepherine Hydrochloride 10 mg
  • PURPOSE

    Purpose
    Analgesic
    Antihistamine
    Decongestant
  • INDICATIONS & USAGE

    Uses  temporarily relieves these symptoms due to common cold and allergies: • nasal congestion • runny nose • sneezing • watery eyes • fever • aches and pains
  • WARNINGS

    Warnings
    Do exceedrecommended dosage
  • ASK DOCTOR

    Ask a doctor before use you have
    • glaucoma • breathing problem such as emphysema or chronic bronchitis • heart disease • diabetes • thyroid disease 
    • difficulty in urination due to enlargement of the prostate gland
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives
  • STOP USE


    Stop taking this product and ask a doctor if you have • pain • fever or symptoms that persist or get worse • new symptoms occur
    • redness or swelling • these may be signs of a serious condition.
  • WHEN USING

    When using this product
    • you may get drowsy • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    •  excitability may occur, especially in children

    If nervousness, dizziness or sleeplessness occur discontinue use and consult a doctor

    If symptoms do not improve within 7 days, or are accompanied by fever, consult a doctor

    If pregnant or breast feeding, ask a health professional before use
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
  • SPL UNCLASSIFIED SECTION

    Drug Interaction Precautions
    • Do not use if you are 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.

  • DOSAGE & ADMINISTRATION

    Directions Adults and children 12 years of age and older; take 1 tablet every 4 hours, do not take more than 6 tablets in 24 hours, unless directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients Lactose, stearic acid, povidone, hydroxypropylmethylcellulose, polyethylene glycol, titanium dioxide, FDC Yellow No. 5

  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    COLD MEDICINE  XL3
    acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-600
    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 MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Coloryellow (light yellow) Scoreno score
    ShapeROUND (Tablet) Size5mm
    FlavorImprint Code XL;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63654-600-6820 in 1 BLISTER PACK
    2NDC:63654-600-0225 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/15/2011
    Labeler - Selder, S.A. de C.V. (824413629)
    Establishment
    NameAddressID/FEIBusiness Operations
    Selder, S.A. de C.V.824413629manufacture
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