IMUBOLIC

Manufacturer
Ayurax
Effective date
2025-10-06
Label type
DIETARY SUPPLEMENT
Version
6
Source
monthly-update
Hydrated at
2026-06-03 17:40:54

Label at a glance#

ProductIMUBOLIC
Active ingredientASCORBIC ACID, cholecalciferol, ZINC OXIDE, FOLIC ACID, ECHINACEA PURPUREA WHOLE, LYSINE HYDROCHLORIDE, TURMERIC, GINGER
Label structure8 sections

Storage and handling

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

Label contents#

Full prescribing information#

HEALTH CLAIM:

STATEMENT OF IDENTITY SECTION

IMUBOLIC Capsules - Dietary Supplement     

Dispensed by Prescription‡

image descriptionimage description

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:

STATEMENT OF IDENTITY SECTION

IMUBOLIC 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.†

IMUBOLIC 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.

IMUBOLIC 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

WARNINGS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.  IMUBOLIC 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. IMUBOLIC capsules should only be used under the direction and supervision of a licensed medical practitioner.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED HEALTH CLAIM:

HEALTH CLAIM SECTION

IMUBOLIC Dietary Supplement
Capsules are clear with a yellow powder inside
Bottles contain 30 capsules, 73308-355-30*
Dispensed by Prescription‡

Manufactured in USA for:

Ayurax, LLC

Fairhope, AL  36532 


Distributed by: Solubiomix, LLC
Rev. 03/2022


* Ayurax 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:

SAFE HANDLING WARNING SECTION

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

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73308-355-30EA - Each73308-355342c6314-9720-4262-a038-39d078921caa12022-07-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73308-35573308-355-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-01full-release2026-06-01 02:51:09

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
AscorASCORBIC ACIDMcGuff Pharmaceuticals, Inc.388aad52-fc01-4784-9791-1dbc80c693062026-05-29Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Skin Renewing SerumASCORBIC ACIDGuangzhou Danting Bath&Body Care Industry Co. Ltd396c2a8d-ac95-cbef-e063-6294a90aff392025-08-23WarningsName fallback
generic name: ASCORBIC ACID

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.