Goutinex
FDA Label NDC 49726-023

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hello Life, Inc. for the product Goutinex (NDC 49726-023). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (per dose), purpose, uses, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Per Dose)

Actaea spicata HPUS
Ammonium phoshoricum HPUS
Belladonna HPUS
Colchicum autumnale HPUS
Formicum acidum HPUS
Fraxinus excelsior HPUS
Ledum palustre HPUS
Natrum carbonicum HPUS
Nux vomica HPUS
Phytolacca decandra HPUS
Rhododendron chrysanthum HPUS
Salicylicum acidum HPUS
Urtica urens HPUS

Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies.
The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Product indications are based on Homeopathic Materia Medica.

Actaea spicata HPUS

Ammonium phoshoricum HPUS

Belladonna HPUS

Colchicum autumnale HPUS

Formicum acidum HPUS

Fraxinus excelsior HPUS

Ledum palustre HPUS

Natrum carbonicum HPUS

Nux vomica HPUS

Phytolacca decandra HPUS

Rhododendron chrysanthum HPUS

Salicylicum acidum HPUS

Urtica urens HPUS


Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Product indications are based on Homeopathic Materia Medica.

Purpose

Actaea spicata HPUS..……………………….Pain
Ammonium phoshoricum HPUS…......……..Heaviness of limbs
Belladonna HPUS……………………….…...Swelling
Colchicum autumnale HPUS………….........Numbness
Formicum acidum HPUS…………………....Gout
Fraxinus excelsior HPUS.…………………..Rheumatism
Ledum palustre HPUS.………………………Pain in joints
Natrum carbonicum HPUS………..………...Cramping in feet and toes
Nux vomica HPUS……………………………Spasms
Phytolacca decandra HPUS………………...Soreness
Rhododendron chrysanthum HPUS……......Stiffness
Salicylicum acidum HPUS……………………Burning
Urtica urens HPUS…………………………….Trouble sleeping

Uses

to temporarily relieve symptoms commonly associated with gout, such as

  • exhaustion
  • dullness
  • drowsiness
  • muscle weakness

Warnings


Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition

Otc - When Using

When using this product, use only as directed.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist or worsen.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, take only on advice of physician.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Directions

Dispense Goutinex directly into mouth, or add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink.  Safe for ages 2 and up.

Dosage By Weight

30-50 lbs 1/2 mL
(13.6-22.6 kg) twice per day

50+ lbs 1 mL
(22.6+ kg) twice per day

Other Information


  • do not use if tamper seal is broken
    • store in a cool, dry place
      • product must not come in contact with metal
        • do not store next to electrical devices or appliances

Inactive Ingredients

citric acid, potassium sorbate, purified ionized mineral water.

Questions Or Comments?

You can email us at [email protected] or call us toll-free at 1.800.875.0850 Monday through Friday, 9am-5pm ET.

Description

  • 30-day supply
  • dropper included
  • Goutinex is made without alcohol or sugar; no gluten added.


    • Mftd for: HelloLife, Inc.
    4460 44th St. SE, Ste. C-600
    Grand Rapids, MI 49512
    FDA Pharmaceutical Establishment
    #1053442, #3009727070
    www.goutinex.com

Principal Display Panel

NDC 49726-023-02

GOUTINEX™

Gout Symptom Relief

To temporarily relieve symptoms commonly associated with gout, such as:

  • joint pain
  • stiffness
  • inflammation
  • swelling

    • Homeopathic (OTC) Medicine
    2 fl oz (59 mL)

    Goutinexcarton (Goutinexcarton)

    Goutinexcarton (Goutinexcarton)

* Please review the disclaimer below.