CYCLO/MAG- cyclobenzaprine hydrochloride, magnesium oxide kit

Cyclo/Mag by

Drug Labeling and Warnings

Cyclo/Mag by is a Prescription medication manufactured, distributed, or labeled by Living Well Pharmacy, Inc., Apotheca Supply, Spectrum Laboratory Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

INGREDIENTS AND APPEARANCE

CYCLO/MAG 
cyclobenzaprine hydrochloride, magnesium oxide kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64038-313

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64038-313-04	1 in 1 KIT

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
Item Code (Source)	NDC: 64038-325
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)	CYCLOBENZAPRINE HYDROCHLORIDE	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64038-325-03	3 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/03/2010

Part 2 of 2

MAGNESIUM OXIDE 
magnesium oxide powder

Product Information
Item Code (Source)	NDC: 64038-131
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM OXIDE - UNII:3A3U0GI71G)	MAGNESIUM OXIDE	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64038-131-60	60 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/03/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/03/2010

Labeler - Living Well Pharmacy, Inc. (070488957)

Registrant - Living Well Pharmacy, Inc. (070488957)

Establishment
Name	Address	ID/FEI	Business Operations
Living Well Pharmacy, Inc.		070488957	repack

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

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