Label: TYLO EXTRA STRENGTH- acetaminophen tablet

  • 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 May 22, 2012

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  • ACTIVE INGREDIENT

    Acetaminophen

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. In case of overdose, get medical help right away and contact a poison control center right away.
  • PURPOSE

    Oral Analgesic

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years and over: Take 2 tablets at bedtime(Do not take more than 2 tablets in a 24 hour time)

  • INACTIVE INGREDIENT


    Povidone
    pregelatinized starch
    stearic acid
  • INDICATIONS & USAGE

    Oral analgesic.

  • WARNINGS

    Do not use this product if you have  had an allergic to Acetaminophen or any of the inactive ingredients. Ask a doctor before taking this product if you have Liver disease or are taking blood thinning medication. Do not take more than directed.If pregnant or breast feeding contact a doctor before using this product. Stop use and consult a doctor if: Pain gets worse or last more than 10 days: If fever gets worse or last more than 3 days: new symptoms appear: redness or swelling appear.

  • PRINCIPAL DISPLAY PANEL

    image of carton image of carton

  • INGREDIENTS AND APPEARANCE
    TYLO  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-002
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white film) Scoreno score
    ShapeOVAL (TABLET) Size17mm
    FlavorImprint Code C15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49638-002-031 in 1 BOX
    1NDC:49638-002-0260 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34305/15/2012
    Labeler - America Medic (071065464)
    Establishment
    NameAddressID/FEIBusiness Operations
    America Medic071065464relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Cispharma,Inc.833171445manufacture
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