Label: CYCLO/MAG- cyclobenzaprine hydrochloride, magnesium oxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 64038-131-60, 64038-313-04, 64038-325-03 - Packager: Living Well Pharmacy, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated March 5, 2010
If you are a consumer or patient please visit this version.
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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.
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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
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INGREDIENTS AND APPEARANCE
CYCLO/MAG
cyclobenzaprine hydrochloride, magnesium oxide kitProduct 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 powderProduct 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 powderProduct 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
