Cyclo Mag

Generic Name: cyclobenzaprine hydrochloride, magnesium oxide

Dosage Form: powder kit
CYCLO/MAG KIT

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

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

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.

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

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

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

Prior to compounding, store Cyclo/Mag Kit at room temperature. Store the final product at room temperature.

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.

CYCLO/MAG 10MG/200MG  cyclobenzaprine hydrochloride, magnesium oxide  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64038-630

Packaging # NDC Package Description Multilevel Packaging 1 64038-630-04 1 KIT In 1 KIT None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE   3 g Part 2 1 BOTTLE   60 g

Part 1 of 2 CYCLOBENZAPRINE HCL  cyclobenzaprine hydrochloride  powder

Product Information NDC Product Code (Source) 64038-620     Route of Administration NOT APPLICABLE DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) CYCLOBENZAPRINE HYDROCHLORIDE 1 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64038-620-03 3 g In 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/17/2010

Part 2 of 2 MAGNESIUM OXIDE  magnesium oxide  powder

Product Information NDC Product Code (Source) 64038-139     Route of Administration NOT APPLICABLE DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM OXIDE (MAGNESIUM OXIDE) MAGNESIUM OXIDE 1 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64038-139-60 60 g In 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/17/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/17/2010

Labeler - Living Well Pharmacy, Inc. (070488957)

Registrant - Living Well Pharmacy, Inc. (070488957)

Establishment
Name	Address	ID/FEI	Operations
Living Well Pharmacy, Inc.		070488957	api manufacture

Establishment
Name	Address	ID/FEI	Operations
Apotheca Supply		859501871	api manufacture

Establishment
Name	Address	ID/FEI	Operations
Spectrum Laboratory Products, Inc.		075295246	api manufacture

Revised: 02/2010Living Well Pharmacy, Inc.