TYLO EXTRA STRENGTH (ACETAMINOPHEN) TABLET [AMERICA MEDIC]

TYLO EXTRA STRENGTH (ACETAMINOPHEN) TABLET [AMERICA MEDIC]
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NDC 49638-002-02, 49638-002-03
Set ID c08fdd22-2e0d-4467-bf70-54fcfef46550
Category HUMAN OTC DRUG LABEL
Packager America Medic
Generic Name
Product Class
Product Number
Application Number PART343
  • 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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