MAGNEBIND 400 RX- vitamin/mineral supplement with magnesium carbonate, calcium carbonate and folic acid tablet, film coated

MagneBind 400 Rx by

Drug Labeling and Warnings

MagneBind 400 Rx by is a Prescription medication manufactured, distributed, or labeled by Nephro-Tech, Inc., Vitamer/VitaCeutical Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

MagneBind 400 Rx is a prescription folic acid supplement with additional nutrients for kidney diaylsis patients. MagneBind 400 Rx is a pink, film-coated, oval shaped tablet.

Suggested Dosage

1-3 tablets with each meal as directed by the physician.

Contraindications

Patients who are hypermagnesemic or who have impaired renal function and are not being dialyzed should not be prescribed MagneBind 400 Rx.

Package Label/Principal Display Panel

59528-0416-05

Rx Only

MagneBind 400 Rx

Mineral/Vitamin Supplement

150 tablets

INGREDIENTS AND APPEARANCE

MAGNEBIND 400 RX 
vitamin/mineral supplement with magnesium carbonate, calcium carbonate and folic acid tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59528-0416
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	115 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	80 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
POLYVINYL ALCOHOL (UNII: 532B59J990)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59528-0416-5	150 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/18/1999

Labeler - Nephro-Tech, Inc. (878520485)

Registrant - Nephro-Tech, Inc. (878520485)

Establishment
Name	Address	ID/FEI	Business Operations
Vitamer/VitaCeutical Labs		806784679	manufacture(59528-0416)