SPL v1
SPL
SPL Set ID 9fd78237-dcf0-409b-8d98-4504c1eaceea
Route
ORAL
Published
Effective Date 2025-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atractylodes Macrocephala Root (116 mg) Carica Papaya Whole (94 mg) Curcuma Longa (turmeric) Root (70 mg) Fibraurea Tinctoria Whole (140 mg) Perilla Frutescens Whole Wolfiporia Cocos Whole Piper Sarmentosum Whole Zingiber Officinale Whole Sigesbeckia Orientalis Whole
Inactive Ingredients
Calcium Stearate Silicon Dioxide Starch, Corn Ferric Oxide Red Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol 6000 Povidone K30 Carboxymethylcellulose Sodium, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: brown Size: 22 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-04-09

Description

Dietary Supplement


Medication Information

Warnings and Precautions
  • If you are pregnant, nursing or have a medical condition, consult your physician before use.
  • Do not use if tamper-evident seal is broken or missing.
  • Keep Out of The Reach of Children.
  • Store in a cool, dry place (59oF-86oF), avoid moisture and light.
Indications and Usage

Description

Dietary Supplement

Section 42232-9

Section 50565-1

Section 55105-1

Section 55106-9

Section 69719-3

Identity

Dietary Supplement

Direction

Adults – Take 2 tablets twice daily (morning and evening) preferably after a meal.

Product Label

Other Ingredients

Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, Ferric Oxides, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene

Glycol 6000, Polyvinylpyrrolidone (PVP), Sodium Carboxymethylcellulose, Talc, Titanium Dioxide.

Safe Handling Warning 

GOUTAMIN

NATURAL GOUT SUPPORT*

Promotes Uric Acid Balance*

Enhances Gout Health*

GOUTAMIN supports the alleviation of gout symptoms by:

- Reducing inflammation & promoting joint health*

- Assisting in lowering uric acid levels in the body*

- Supporting healthy kidney function*

- Enhancing joint mobility and flexibility*

- Providing antioxidant benefits to fight oxidative stress*

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


Structured Label Content

Indications and Usage (34067-9)

Warnings and Precautions (34071-1)
  • If you are pregnant, nursing or have a medical condition, consult your physician before use.
  • Do not use if tamper-evident seal is broken or missing.
  • Keep Out of The Reach of Children.
  • Store in a cool, dry place (59oF-86oF), avoid moisture and light.
Section 42232-9 (42232-9)

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Section 69719-3 (69719-3)

Identity

Dietary Supplement

Direction

Adults – Take 2 tablets twice daily (morning and evening) preferably after a meal.

Product Label (Product label)

Other Ingredients (Other ingredients)

Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, Ferric Oxides, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene

Glycol 6000, Polyvinylpyrrolidone (PVP), Sodium Carboxymethylcellulose, Talc, Titanium Dioxide.

Safe Handling Warning  (Safe handling warning )

GOUTAMIN

NATURAL GOUT SUPPORT*

Promotes Uric Acid Balance*

Enhances Gout Health*

GOUTAMIN supports the alleviation of gout symptoms by:

- Reducing inflammation & promoting joint health*

- Assisting in lowering uric acid levels in the body*

- Supporting healthy kidney function*

- Enhancing joint mobility and flexibility*

- Providing antioxidant benefits to fight oxidative stress*

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)