Macuzin

MACUZIN- folic acid, ascorbic acid, .alpha.-tocopherol acetate, dl-, zinc oxide, copper, lutein and zeaxanthin 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.

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
(click image for full-size original)
MACUZIN
macuzin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69336-800
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 500 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 400 [iU]
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 80 mg
COPPER (COPPER) COPPER 2 mg
LUTEIN (LUTEIN) LUTEIN 10 mg
ZEAXANTHIN (ZEAXANTHIN) ZEAXANTHIN 2 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
WATER
SOYBEAN OIL
YELLOW WAX
LECITHIN, SOYBEAN
GLYCERIN
CARAMEL
FD&C BLUE NO. 1
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape capsule Size 22mm
Flavor Imprint Code Macuzin
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69336-800-30 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/30/2015
Labeler — Sterling-Knight Pharmaceuticals, LLC (079556942)
Establishment
Name Address ID/FEI Operations
VIVA PHARMACEUTICAL INC. 253288898 manufacture (69336-800)

Revised: 05/2015 Sterling-Knight Pharmaceuticals, LLC

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