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Lexazin Capsules Prescribing Information

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

Medically reviewed by Drugs.com. Last updated on Oct 4, 2023.

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.

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.

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

Label

LEXAZIN
lexazin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69336-358
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL500 [iU]
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE25 mg
PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS12.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN5 mg
NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH5 mg
COENZYME Q10, (2Z)- (UNII: U705VLF0VW) (COENZYME Q10, (2Z)- - UNII:U705VLF0VW) COENZYME Q10, (2Z)-50 mg
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)
GELATIN (UNII: 2G86QN327L)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
Product Characteristics
Colorbrown (Tan) Scoreno score
ShapecapsuleSize19mm
FlavorImprint Code314
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69336-358-3030 in 1 PACKAGE; Type 0: Not a Combination Product01/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/02/2018
Labeler - Sterling Knight Pharmaceuticals LLC (079556942)
Registrant - Sterling Knight Pharmaceuticals LLC (079556942)
Establishment
NameAddressID/FEIBusiness Operations
Sterling Knight Pharmaceuticals LLC079556942manufacture(69336-358)

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