Immune System Moderator

Manufacturer
Sanaura Group LIMITED
Effective date
2024-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:15

Label at a glance#

ProductImmune System Moderator
Active ingredientYEAST .BETA.-D-GLUCAN
Label structure15 sections

Storage and handling

Other information: Store at 5-30℃; Keep out of direct sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: YEAST .BETA.-D-GLUCAN 800 mg/ 10 g

OTC - PURPOSE SECTION

Purpose: Immunomodulatory

INDICATIONS & USAGE SECTION

Use to:

Regulate the human immune system; Treat rheumatoid arthritis

WARNINGS SECTION

Warnings: Do not use if you are allergic to this product and its ingredients.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are:

Children under 15 years old

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

Other diseases, Or take some medicines

OTC - WHEN USING SECTION

When using this product:

Take before meals, Take it half an hour before going to bed

OTC - STOP USE SECTION

Stop use and ask a doctor if:

There was no sign of relief after taking for 4 weeks.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

Take one bottle orally with water, three times daily.

For internal use only.

STORAGE AND HANDLING SECTION

Other information:

Store at 5-30℃;

Keep out of direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients: ZIYUGLYCOSIDE II, Corn Starch

OTC - QUESTIONS SECTION

Questions? 123-555-1234

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Immune System Moderator 84611-101-01Immune System Moderator 84611-101-01Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84611-101-012026-01-29C16284748780-149896155-d81a-586f-e063-e6dba90add90Immune System Moderator 84611-101
84611-101-022026-01-29C16284748780-149896155-d81a-586f-e063-e6dba90add90Immune System Moderator 84611-101

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84611-101-01Immune System Moderator10 g in 1 BAGGRANULE101
84611-101-02Immune System Moderator10 g in 1 BOTTLEGRANULE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84611-101IMMUNE SYSTEM MODERATOR (YEAST .BETA.-D-GLUCAN) GRANULE [SANAURA GROUP LIMITED]12 package rows20240816_1fb0a1d6-9188-d369-e063-6394a90a5e9c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84611-10184611-101-01, 84611-101-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1fb0a1d6-9189-d369-e063-6394a90a5e9c1fb0a1d6-9188-d369-e063-6394a90a5e9c2024-08-15WarningsExact identifier
spl id: 1fb0a1d6-9189-d369-e063-6394a90a5e9c
spl set id: 1fb0a1d6-9188-d369-e063-6394a90a5e9c

Reported adverse events (FAERS/openFDA)#

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