MedPath

Gout Relief 3310-S

Approved
Approval ID

3afaa7d9-3de3-52d9-e063-6294a90a54ec

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 2, 2025

Manufacturers
FDA

Bispit Canada Ltd.

DUNS: 243332192

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CELERY SEED, MEDICAGO SATIVA WHOLE,CHICORY ROOT

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85631-003
Product Classification
G
Generic Name
CELERY SEED, MEDICAGO SATIVA WHOLE,CHICORY ROOT
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2025
FDA Product Classification

INGREDIENTS (14)

GLUCOSAMINE HYDROCHLORIDEActive
Quantity: 130 mg in 1.3 g
Code: 750W5330FY
Classification: ACTIB
MORUS ALBA LEAFActive
Quantity: 39 mg in 1.3 g
Code: M8YIA49Q2P
Classification: ACTIB
LICORICEActive
Quantity: 2.6 mg in 1.3 g
Code: 61ZBX54883
Classification: ACTIB
PUERARINActive
Quantity: 65 mg in 1.3 g
Code: Z9W8997416
Classification: ACTIB
BUCKWHEATActive
Quantity: 91 mg in 1.3 g
Code: N0Y68724R3
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 26 mg in 1.3 g
Code: 451W47IQ8X
Classification: ACTIB
MEDICAGO SATIVA WHOLEActive
Quantity: 260 mg in 1.3 g
Code: DJO934BRBD
Classification: ACTIB
TEA LEAFActive
Quantity: 65 mg in 1.3 g
Code: GH42T47V24
Classification: ACTIB
CELLULOSE GUMInactive
Code: K679OBS311
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CELERY SEEDActive
Quantity: 260 mg in 1.3 g
Code: 1G1EAA320L
Classification: ACTIB
MALTOSYL-ISOMALTOTETRAOSEInactive
Code: B9HR7A9UFR
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CHICORY ROOTActive
Quantity: 234 mg in 1.3 g
Code: 090CTY533N
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/28/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/28/2025

Dissolved CrystallizationKidney StoneGallstone< Urinary Calculus

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/28/2025

CELERY SEED 1G1EAA320L 20.00%
MEDICAGO SATIVA WHOLE DJO934BRBD 20.00%
CHICORY ROOT 090CTY533N 18.00%
GLUCOSAMINE HYDROCHLORIDE 750W5330FY 10.00%
BUCKWHEAT N0Y68724R3 7.00%
TEA LEAF GH42T47V24 5.00%
PUERARIN Z9W8997416 5.00%
MORUS ALBA LEAF M8YIA49Q2P 3.00%
LICORICE 61ZBX54883 0.20%
SODIUM CHLORIDE 451W47IQ8X 2.00%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/28/2025

This product has a significanteffect on gout, crystal deposits,and hyperuricemia;
elt has an auxiliary effectof mitigating kidney stonesand bladder stones

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/28/2025

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/28/2025

The product has great somatosensation after taking it atleast 21 days in the earty stage;3. Elevated uric acid or gout recurrence and site changes arenoral in the earty stage of taking this product;

WARNINGS SECTION

LOINC: 34071-1Updated: 7/28/2025

For your health, please read the followingcarefully
1. The use of three vials can effectivety dissolve crystallization (ittakes time to dissolve crystallization);2. The product has great somatosensation after taking it atleast 21 days in the early stage;3. Elevated uric acid or gout recurrence and site changes arenormal in the early stage of taking this product;4. Try not to drink alcohol or drink less 15 days before takingthis product;
5. This product certainly has significant effect on gout,crystallization and hyperuricemia;

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/28/2025

Do not use if seal is broken.

Do not eat freshness packet enclosed.

Keep out of direct sunlight, high temperature, and humidity.

Store in a cool, dry place.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/28/2025

MICROCRYSTALLINE CELLULOSE
MALTOSYL-ISOMALTOTETRAOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
MAGNESIUM STEARATE

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