Label: CYCLO/MAG- cyclobenzaprine hydrochloride, magnesium oxide kit

  • NDC Code(s): 64038-131-60, 64038-313-04, 64038-325-03
  • Packager: Living Well Pharmacy, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 5, 2010

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    RX #: 278390    1/4/2010     LWP MD

    CYLCOBENZAPRINE HCL #3 GM

    LOT: 292090707                                HEALTH: 2

    MFG: APOTHECARES                    FIRE:1

    NDC: 37803-0368-08                          REACTIVITY:0

    BATCH #: 01041004                          CAS:6202-23-9

  • PRINCIPAL DISPLAY PANEL

    CyclobenzaprineHCL

  • PRINCIPAL DISPLAY PANEL

    RX #: 267654   11/10/2009     LWP MD

    MAGNESIUM OXIDE POWDER HVY #60 GM

    LOT: YP0232                                  HEALTH: 2

    MFG: SPECTRUM                        FIRE:0

    NDC: 49452-4260-02                                 REACTIVITY:0

    BATCH #: 11100901                                CAS:1309-48-4
  • PRINCIPAL DISPLAY PANEL

    MagnesiumOxidePowder

  • DESCRIPTION

    1. RX Only

    For Prescription Compounding Only


    Cyclo/Mag Kit
    Cyclobenzaprine HCl and Magnesium  Oxide Compound Kit

    Description

    Each Cyclo/Mag Kit is comprised of 3 grams of cyclobenzaprine hydrochloride powder, USP and
    60 grams of magnesium oxide heavy powder.

    Certificate of Analysis on File

    Cyclo/Mag Kit also contains 60 grams of Lactose Monohydrate (Spray dried) powder and 0.15 grams of
    riboflavin USP powder. When compounded, the final product provides a homogeneous product of 300
    capsules each capsule containing 10mg of cyclobenzaprine and 200mg of magnesium oxide.
  • INDICATIONS & USAGE

    Equipment

    Required supplies needed to compound this kit


    Equipment
    Item
    Quantity
    Cyclobenzaprine HCl  (Included)
    3 grams
    Magnesium Oxide Heavy Powder (Included)
    60 grams
    Lactose Monohydrate Spray Dried Powder ( Included)
    60 grams
    Riboflavin Powder (Included)
    0.15 grams
    Red 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. Do not use metal bowls or spatulas while

    compounding this product.

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

  • STORAGE AND HANDLING

    Prior to compounding, store Cyclo/Mag 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

  • INGREDIENTS AND APPEARANCE
    CYCLO/MAG 
    cyclobenzaprine hydrochloride, magnesium oxide kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64038-313
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64038-313-041 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 3 g
    Part 21 BOTTLE 60 g
    Part 1 of 2
    CYCLOBENZAPRINE HCL 
    cyclobenzaprine hydrochloride powder
    Product Information
    Item Code (Source)NDC:64038-325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64038-325-033 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/03/2010
    Part 2 of 2
    MAGNESIUM OXIDE 
    magnesium oxide powder
    Product Information
    Item Code (Source)NDC:64038-131
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM OXIDE - UNII:3A3U0GI71G) MAGNESIUM OXIDE1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64038-131-6060 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/03/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/03/2010
    Labeler - Living Well Pharmacy, Inc. (070488957)
    Registrant - Living Well Pharmacy, Inc. (070488957)
    Establishment
    NameAddressID/FEIBusiness Operations
    Living Well Pharmacy, Inc.070488957repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Supply859501871api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Spectrum Laboratory Products, Inc.075295246api manufacture