Label: TRAMAPAP- tramadol hydrochloride, acetaminophen kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 25, 2010

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  • PRINCIPAL DISPLAY PANEL

    LWP

    381 Van Ness Ave. Suite 1507

    Torrance CA, 90501

    S/N: LWP304326                              3/29/2010                     LWP,MD

    ACETAMINOPHEN GRANULAR, USP #75 GM

    BATCH: 03292010Z                                                            HEALTH: 1

    MFG: LIVING WELL PHARMACY                                        FIRE: 1

    NDC: 64038-0135-75                                                           REACTIVITY: 0

    CAS #: 103-90-2
  • PRINCIPAL DISPLAY PANEL


    Acetaminophen.Granular.USP.label

  • PRINCIPAL DISPLAY PANEL

    LWP

    381 Van Ness Ave. Suite 1507

    Torrance CA, 90501

    S/N: LWP307039                              4/6/2010                     LWP,MD

    TRAMADOL HCL #15GM

    BATCH: 04062010Z                                                            HEALTH: 2

    MFG: LIVING WELL PHARMACY                                        FIRE: 1

    NDC: 64038-0738-15                                                           REACTIVITY: 0

    CAS #: 73806-49-2
  • PRINCIPAL DISPLAY PANEL

    Tramadol 15 GM
  • DESCRIPTION

    1. RX Only

    For Prescription Compounding Only


    Tramapap Kit
    Tramadol HCl and Acetaminophen Compound Kit

    Description

    Each Tramapap Kit is comprised of 15 grams of tramadol hydrochloride powder and  75 grams of acetaminophen powder.

    Certificate of Analysis on File

    Tramapap Kit also contains 23.25 grams of Lactose Monohydrate (Spray dried) powder and 1.5 grams of
    riboflavin USP powder. When compounded, the final product provides a homogeneous product of 300
    capsules each capsule containing 50mg of tramadol and 250mg of acetaminophen.
  • INDICATIONS & USAGE

    Equipment

    Required supplies needed to compound this kit


    Equipment
    Item
    		Quantity
    Tramadol HCl (Included)
    		15 grams
    Acetaminophen (Included)
    		75 grams
    Lactose Monohydrate Spray Dried Powder ( Included)
    		23.25 grams
    Riboflavin Powder (Included)
    		1.5 grams
    Red/Blue #1 Capsules ( Required Not Included)
    		300 Capsules




  • DRUG & OR LABORATORY TEST INTERACTIONS

    Equipment

    Recommended supplies not included in this kit

    Equipment
    Item
    		Quantity
    16 oz Glass Mortar and Pestle
    		1 each
    300 Capsule Machine Number 2 Notch
    		1
    Scraper ( Recommended Not Included)
    		1
    Tamper (Recommended Not Included)
    		1
    Capsule Locker (Recommended Not Included)
    		1


  • DOSAGE & ADMINISTRATION

    Directions

    1. Using a 16 oz mortar and pestle triturate powders well to reduce particle size until uniform.

    2. Using a 300 capsule machine encapsulate triturate powder mixture into number 1 red/blue capsules

  • STORAGE AND HANDLING

    Prior to compounding, store Tramapap Kit at room temperature. Store the final product at room temperature.

  • WARNINGS AND PRECAUTIONS

    Final product for oral use only. Keep out the reach of children. Compounded product, as dispensed,

    is stable for at least 180 days or the time remaining on the expiration date of any given ingredient,

    which ever is shorter.

  • PRINCIPAL DISPLAY PANEL

    Directions
  • PRINCIPAL DISPLAY PANEL

    tramapapuse
  • INGREDIENTS AND APPEARANCE
    TRAMAPAP 
    tramadol hydrochloride, acetaminophen kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64038-059
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64038-059-031 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 g
    Part 21 BOTTLE 75 g
    Part 1 of 2
    TRAMADOL HCL 
    tramadol hydrochloride powder
    Product Information
    Item Code (Source)NDC:64038-738
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tramadol Hydrochloride (UNII: 9N7R477WCK) (Tramadol - UNII:39J1LGJ30J) Tramadol Hydrochloride1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64038-738-1515 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/07/2010
    Part 2 of 2
    ACETAMINOPHEN CRYSTAL 
    acetaminophen powder
    Product Information
    Item Code (Source)NDC:64038-135
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64038-135-7575 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/07/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/07/2010
    Labeler - Living Well Pharmacy, Inc. (070488957)
    Registrant - Living Well Pharmacy, Inc. (070488957)
    Establishment
    NameAddressID/FEIBusiness Operations
    Living Well Pharmacy, Inc.070488957api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Letco830193582api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Spectrum Laboratory Products, Inc.075295246api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Medisca627218576api manufacture
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