XYZMUNE: Package Insert and Label Information

XYZMUNE- ascorbic acid, cholecalciferol, zinc oxide, folic acid, echinacea purpurea whole, lysine hydrochloride, turmeric and ginger capsule
Basiem, LLC

HEALTH CLAIM:

XYZMUNE Capsules — Dietary Supplement

Dispensed by Prescription

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OTHER INGREDIENTS: gelatin, calcium stearate, silica, organic mushroom (Pleurotus eryngii), organic turkey tail (Trametes versicolor), organic cordyceps (Cordyceps militaris), organic reishi (Ganoderna lucidum) organic himematsutake (Agaricus blazei), organic lion’s mane (Hericium erincaces), organic antrodia (Taiwanofungus camphoratus (Antrodia camphorate)), organic maitake (Grifola frondosa)

DESCRIPTION:

XYZMUNE is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good immune health is needed.

XYZMUNE is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are “Generally Recognized as Safe” (GRAS) for their intended use.

XYZMUNE should be administered under the supervision of a licensed medical practitioner.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease.

WARNING AND PRECAUTIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. XYZMUNE capsules should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.


KEEP OUT OF REACH OF CHILDREN

PRECAUTION
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. XYZMUNE capsules should only be used under the direction and supervision of a licensed medical practitioner.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling 1-844-551-9911 or the FDA by calling 1-800-FDA-1088.

DOSAGE & ADMINISTRATION

Usual adult dose is 1 capsule taken orally once or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

XYZMUNE Dietary Supplement
Capsules are clear with a yellow powder inside
Bottles contain 30 capsules, 69597-355-30*
Dispensed by Prescription

Manufactured in USA for:
Basiem, LLC
Madisonville, LA 70447


Distributed by: Solubiomix, LLC
Rev. 04/2020


* Basiem does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.
The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product by prescription. This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

1. Federal Register Notice of August 2, 1973 (38 FR 20750)
2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3. Federal Register Notice of March 5, 1996 (61 FR 8760)

STORAGE AND HANDLING:

STORAGE: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP]

PACKAGE LABEL:

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XYZMUNE
ascorbic acid, cholecalciferol, folic acid, zinc, echinacea, l-lysine hcl, tumeric, ginger capsule
Product Information
Product Type Item Code (Source) NDC:69597-355
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 500 mg
cholecalciferol (cholecalciferol) cholecalciferol 0.015 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 16 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
ECHINACEA PURPUREA WHOLE (ECHINACEA PURPUREA WHOLE) ECHINACEA PURPUREA WHOLE 30 mg
LYSINE HYDROCHLORIDE (LYSINE) LYSINE 10 mg
TURMERIC (TURMERIC) TURMERIC 10 mg
GINGER (GINGER) GINGER 5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
CALCIUM STEARATE
SILICA DIMETHYL SILYLATE
PLEUROTUS ERYNGII WHOLE
TRAMETES VERSICOLOR WHOLE
CORDYCEPS MILITARIS WHOLE
GANODERMA LUCIDUM WHOLE
AGARICUS BLAZEI WHOLE
HERICIUM AMERICANUM WHOLE
TAIWANOFUNGUS CAMPHORATUS WHOLE
GRIFOLA FRONDOSA WHOLE
Product Characteristics
Color yellow Score no score
Shape capsule Size 23mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69597-355-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 04/08/2020
Labeler — Basiem, LLC (079686680)

Revised: 10/2020 Basiem, LLC

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