Label: XL3 XTRA- acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled capsule, liquid filled

  • 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 August 7, 2015

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

  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredient in each capsule

    Acetaminophen 250mg

    Phenylepherine Hydrochloride 5mg

    Chlorpheniramide Maleate 2mg

    Dextromethorphan Hydrobromide 10mg

  • PURPOSE

    PURPOSE

    Analgesic

    Decongestant

    Antihistamine

    Antitussive

  • USER SAFETY WARNINGS

    USES

    Temporaruly relieves the symptoms due to common cold and allergies: Cough, nasal congestion, runny nose, sneezing, watery eyes, fever, aches and pains.

    WARNINGS

    DO NOT USE More than recommended dosage for pain more than 7 days for fever more than 3 days for children under 12 age with any other product containing acetaminophen.

  • WARNINGS AND PRECAUTIONS

    Alcohol Warning:If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relivers fever reducers. Acetaminophen may casuse liver damage

    Ask a doctor befor use you have

    • Glaucoma, breathing problems such as emphysema or chronic bronchitis, heart disease, diabetes, thyroid disease.
    • difficulty in urination due to enlagement of the prostate gland

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

    Do not take this product for persistent or chronic cough such as occur with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucis) unless directed by doctor

  • STOP USE

    Stop taking this product and ask a doctor if yoi have pain, fever or sympoms that persist or get worse ,

    new symptoms occur

    redness or swelling these may be 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
    • excitabiloty may occur, especially in children

    if nervousness, dizziness or spleeplessness occur discontinue use and consult a doctor

  • ASK DOCTOR

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

    if you are 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 contac a poison control center immediately. Prompt medical attention is critical for adults as well as children ever if you do not notice any sings or symptoms .

  • DRUG INTERACTIONS

    Drug unteraction precautions

    do not use if you are taking a prescription monoamine oxidase ihibitor (MAOI) (certain drug for depression, psychoatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your presctiption 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 2 capsules every 4 hours. Do not take more than 12 capsules in 24 hours, unless directed by doctor. For children under 12 years of age consult a doctor

  • INACTIVE INGREDIENT

    DC red No. 33, FDC Blue No.1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, polyethylene glycol, water.

  • PRINCIPAL DISPLAY PANEL

    XL3 XTRA

  • WARNINGS

    WARNINGS

    DO NOT USE More than recommended dosage for pain more than 7 days for fever more than 3 days for children under 12 age with any other product containing acetaminophen.

  • INDICATIONS & USAGE

    Adults and children 12 years of age and older; take 2 capsules every 4 hours. Do not take more than 12 capsules in 24 hours, unless directed by doctor. For children under 12 years of age consult a doctor

  • INGREDIENTS AND APPEARANCE
    XL3 XTRA 
    acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-440
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 1 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 1 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg  in 1 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScorescore with uneven pieces
    ShapeCAPSULE (SOFT LIQUID FILLED CAPSULE) Size10mm
    FlavorImprint Code Xtra
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-440-0120 mg in 1 BLISTER PACK; Type 0: Not a Combination Product09/02/2015
    2NDC:69772-440-0212 mg in 1 BLISTER PACK; Type 0: Not a Combination Product09/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/07/2015
    Labeler - Teresa Cecena DBA Genesis (078760958)
    Registrant - Teresa Cecena (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    TERESA CECENA078760958relabel(69772-440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Selder SA DE CV824413629manufacture(69772-440)