Label: XL-DOL- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 20, 2011

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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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