XL-DOL (ACETAMINOPHEN ) TABLET [SELDER, S.A. DE C.V. ]

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XL-DOL (ACETAMINOPHEN ) TABLET [SELDER, S.A. DE C.V. ]
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NDC 63654-500-20
Set ID c6b28c7d-a649-43d5-bd93-a7364c509d11
Category HUMAN OTC DRUG LABEL
Packager Selder, S.A. de C.V.
Generic Name
Product Class
Product Number
Application Number PART343
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  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)
    Acetaminophen USP 500 mg
  • PURPOSE

    Purpose
    Analgesic
  • INDICATIONS & USAGE

    Uses temporarily relieves minor aches and pains associated with: •common cold •headaches •toothache •muscular aches •minor pain from arthritis •reduce fever
  • WARNINGS

    Warning: Do not use: •with any other product containing acetaminophen  •for more than 10 days for pain, unless directed by a doctor •for more than 3 days for fever, unless directed by a doctor
  • ASK DOCTOR

    Stop using the product and ask a doctor if •symptoms do not improve •new symptoms occur •pain or fever persist or gets worse •redness or swelling is present
  • KEEP OUT OF REACH OF CHILDREN

    Keep out the reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately.Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use.
  • SPL UNCLASSIFIED SECTION


    Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
  • INACTIVE INGREDIENT


    Inactive Ingredients  povidone, stearic acid, sodium croscarmellose, hydroxypropylmethylcellulose, titanium dioxide, polydextrose, triacetin, polyethylene glycol, DC Yellow No.10
  • DOSAGE & ADMINISTRATION

    Directions Adults and children 12 years and over: take 1 to 2 tablets every 4 to 6 hours as needed, do not take more than 8 tablets in 24 hours unless directed by a doctor, for children under 12 years of age consult a doctor.
  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    XL-DOL  
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    TRIACETIN (UNII: XHX3C3X673)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    Coloryellow (light yellow) Score2 pieces
    ShapeROUND (Tablet) Size6mm
    FlavorImprint Code XL;DOL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63654-500-2020 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/15/2011
    Labeler - Selder, S.A. de C.V. (824413629)
    Establishment
    NameAddressID/FEIBusiness Operations
    Selder, S.A. de C.V. 824413629manufacture
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