Cyclo/mag
FDA Label NDC 64038-313

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Living Well Pharmacy, Inc. for the product Cyclo/mag (NDC 64038-313). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, description, indications & usage, drug & or laboratory test interactions, dosage & administration, storage and handling, warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Cyclobenzaprinehcl (Cyclobenzaprinehcl)

Cyclobenzaprinehcl (Cyclobenzaprinehcl)

RX #: 267654   11/10/2009     LWP MDMAGNESIUM OXIDE POWDER HVY #60 GMLOT: YP0232                                  HEALTH: 2MFG: SPECTRUM                        FIRE:0NDC: 49452-4260-02                                 REACTIVITY:0BATCH #: 11100901                                CAS:1309-48-4

Magnesiumoxidepowder (Magnesiumoxidepowder)

Magnesiumoxidepowder (Magnesiumoxidepowder)

Directions (Directionsforuse)

Directions (Directionsforuse)

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


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.

* Please review the disclaimer below.