MACUZIN- macuzin capsule 
Sterling-Knight Pharmaceuticals, LLC

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.

----------

Macuzin
Rx Only

DESCRIPTION

Macuzin is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation. Macuzin should be administered under the supervision of a licensed medical practitioner.

Each capsule contains:Folic Acid:1mg, Vitamin C (ascorbic acid):500mg, Vitamin E (dl-alpha tocopherol):800IU, Zinc(oxide)80mg, Copper (oxide): 2mg, Lutein :10 mg, Zeaxanthin:2 mg, Each capsule contains the following inactive ingredients: Gelatin, FD&C Blue #1, Titanium Dioxide, water

INDICATIONS AND USAGE

Macuzin is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS AND PRECAUTIONS

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

This medication is generally well tolerated. Notify your doctor if you experience: nausea, loss of appetite, vomiting, stomach cramps, dry mouth, increased thirst, increased urination, muscle or bone pain,headache, weakness, weight loss, dizziness. If you notice other effects not listed above, contact your doctor or pharmacist.

DOSAGE AND ADMINISTRATION

Take one capsule daily with or without food or as directed by a physician.

HOW SUPPLIED

Macuzin capsules are supplied as blue capsules printed with 800 dispensed in HDPE plastic bottles of 30ct.

NDC 69336-800-30

STORAGE

Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

Rx Only

Reserved for Professional Recommendation

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for

Sterling-Knight Pharmaeuticals,LLC

Ripley, MS 38663

Rev.01/15-1

MacuzinImage

MACUZIN 
macuzin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69336-800
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID500 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-400 [iU]
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 mg
LUTEIN (UNII: X72A60C9MT) (LUTEIN - UNII:X72A60C9MT) LUTEIN10 mg
ZEAXANTHIN (UNII: CV0IB81ORO) (ZEAXANTHIN - UNII:CV0IB81ORO) ZEAXANTHIN2 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
SOYBEAN OIL (UNII: 241ATL177A)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARAMEL (UNII: T9D99G2B1R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapecapsuleSize22mm
FlavorImprint Code Macuzin
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69336-800-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/201507/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/30/201507/30/2018
Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)
Establishment
NameAddressID/FEIBusiness Operations
VIVA PHARMACEUTICAL INC.253288898manufacture(69336-800)

Revised: 7/2018
 
Sterling-Knight Pharmaceuticals, LLC