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Lexazin Capsules Prescribing Information

Package insert / product label
Generic name: lexazin
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Jan 23, 2023.

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.

HEALTH CLAIM:

Lexazin Capsule

Dispensed by Prescription†

Supplement Facts
Serving Size: 1 Capsule

Servings per Bottle: 30
Amount Per Serving: % Daily Value
Vitamin C (as ascorbic acid) 125 mg 208%
Vitamin D3 (as cholecalciferol) 500 IU 125%
Thiamin (Vitamin B1 as thiamin HCl) 25 mg 1,667%
Vitamin B6 (as pyridoxal 5’ phosphate) 12.5 mg 625%
Folic Acid 1 mg 250%
Vitamin B12 (as methylcobalamin) 1 mg 16,667%
NADH (reduced nicotinamide-adenine dinucleotide) 5 mg *
CoEnzyme Q-10 (ubiquinone) 50 mg *
*Daily Values (DV) not established.

OTHER INGREDIENTS: Yellow Wax(bees), Gelatin(bovine), Soybean Oil, Glycerin, Deionized Water, Lecithin(soy), Titanium Dioxide

DESCRIPTION:

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

Related/similar drugs

acetylcysteine, ascorbic acid, Vitamin C, biotin, multivitamin, niacin, l-methylfolate

WARNING 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.

Lexazin Capsules Dosage and Administration

Take 1 to 2 capsule daily as directed by a physician.

HOW SUPPLIED HEALTH CLAIM:

Lexazin Capsules are supplied as white capsules printed with 356 dispensed in HDPE plastic bottles of 30ct.

NDC 69336-358-30

Reserved for Professional RecommendationAll 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.

STORAGE AND HANDLING:

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.

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.

CONTRAINDICATIONS:

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

INDICATIONS AND USAGE:

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

Display Package

LEXAZIN
lexazin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69336-358
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 125 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 500 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 25 mg
PYRIDOXAL PHOSPHATE ANHYDROUS (PYRIDOXAL PHOSPHATE ANHYDROUS) PYRIDOXAL PHOSPHATE ANHYDROUS 12.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
METHYLCOBALAMIN (METHYLCOBALAMIN) METHYLCOBALAMIN 5 mg
NADH (NADH) NADH 5 mg
COENZYME Q10, (2Z)- (COENZYME Q10, (2Z)-) COENZYME Q10, (2Z)- 50 mg
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX
GELATIN
SOYBEAN OIL
GLYCERIN
LECITHIN, SOYBEAN
TITANIUM DIOXIDE
WATER
Product Characteristics
Color brown (Tan) Score no score
Shape capsule Size 19mm
Flavor Imprint Code 314
Contains
Packaging
# Item Code Package Description
1 NDC:69336-358-30 30 CAPSULE in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/02/2018
Labeler - Sterling Knight Pharmaceuticals LLC (079556942)
Registrant - Sterling Knight Pharmaceuticals LLC (079556942)
Establishment
Name Address ID/FEI Operations
Sterling Knight Pharmaceuticals LLC 079556942 manufacture(69336-358)
Sterling Knight Pharmaceuticals LLC

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