FDA.reportPublic FDA data

Cyclo/Mag

Manufacturer
Living Well Pharmacy, Inc. | Apotheca Supply | Spectrum Laboratory Products, Inc.
Effective date
2010-03-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:09:19

Label at a glance#

ProductCyclo/Mag
Active ingredientCYCLOBENZAPRINE HYDROCHLORIDE, MAGNESIUM OXIDE
Label structure11 sections

Storage and handling

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

Label contents#

Full prescribing information#

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CyclobenzaprineHCLCyclobenzaprineHCL

PACKAGE LABEL.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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MagnesiumOxidePowderMagnesiumOxidePowder

DESCRIPTION SECTION

  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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DirectionsDirections

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
999731cyclobenzaprine HCl 10 MG / magnesium oxide 200 MG Oral CapsulePSN2
999731cyclobenzaprine hydrochloride 10 MG / magnesium oxide 200 MG Oral CapsuleSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CYCLOBENZAPRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64038-313-042019-10-21C16284748780-1956f9ecf-c276-621f-e053-dbdaa90a74adCYCLO/MAG KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64038-131-60Cyclo/Mag60 g in 1 BOTTLEPOWDER60 g1 g in 1g2
64038-313-04Cyclo/Mag1 in 1 KITKIT12
64038-325-03Cyclo/Mag3 g in 1 BOTTLEPOWDER3 g1 g in 1g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64038-131CYCLO/MAG (CYCLOBENZAPRINE HYDROCHLORIDE, MAGNESIUM OXIDE) KIT [LIVING WELL PHARMACY, INC.]2Unmatched20100719_ca38d5da-07f9-4b37-b69f-bc501a197914.zip
64038-313CYCLO/MAG (CYCLOBENZAPRINE HYDROCHLORIDE, MAGNESIUM OXIDE) KIT [LIVING WELL PHARMACY, INC.]2Legacy NDC, 3 package rows20100719_ca38d5da-07f9-4b37-b69f-bc501a197914.zip
64038-325CYCLO/MAG (CYCLOBENZAPRINE HYDROCHLORIDE, MAGNESIUM OXIDE) KIT [LIVING WELL PHARMACY, INC.]2Unmatched20100719_ca38d5da-07f9-4b37-b69f-bc501a197914.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2P2
MAGNESIUM OXIDEACTIVE INGREDIENT3A3U0GI71G2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TI2
MAGNESIUM OXIDEACTIVE MOIETY3A3U0GI71G2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64038-31364038-313-04
64038-32564038-325-03
64038-13164038-131-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOBENZAPRINE HYDROCHLORIDE0VE05JYS2PACTIB
MAGNESIUM OXIDE3A3U0GI71GACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
50685541-a4de-4c8a-b0d4-ec14ce0b69daca38d5da-07f9-4b37-b69f-bc501a1979142010-03-09WarningsExact identifier
spl set id: ca38d5da-07f9-4b37-b69f-bc501a197914

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.