FDA Label for Cyclo/mag
View Indications, Usage & Precautions
Cyclo/mag Product Label
The following document was submitted to the FDA by the labeler of this product Living Well Pharmacy, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package Label.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
Description
- 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
| 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
| 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.
* Please review the disclaimer below.
