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Cyclo Mag

Generic name: cyclobenzaprine hydrochloride, magnesium oxide
Dosage form: powder kit

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.

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 LABEL Item Code (Source) NDC:64038-630
Packaging
# Item Code Package Description
1 NDC:64038-630-04 1 KIT (KIT) 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:64038-620
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
Packaging
# Item Code Package Description
1 NDC:64038-620-03 3 g in 1 BOTTLE
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
Item Code (Source) NDC: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
Packaging
# Item Code Package Description
1 NDC:64038-139-60 60 g in 1 BOTTLE
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
Living Well Pharmacy, Inc.