Drug Facts

Drug Facts

SPL v10

SPL

SPL Set ID 4243e27f-ce96-4e73-9948-be88c5d02726

Route

ORAL

Published

Effective Date 2015-11-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Actaea Spicata Root (10 [hp_X]) Phosphate Ion Atropa Belladonna Colchicum Autumnale Bulb Formic Acid Carbonate Ion Strychnos Nux-vomica Seed Phytolacca Americana Root Rhododendron Aureum Leaf Salicylic Acid Urtica Urens Ledum Palustre Twig Fraxinus Excelsior Leaf

Inactive Ingredients

Water Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2011-11-09

Description

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

Medication Information

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

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

Uses

to temporarily relieve symptoms commonly associated with gout, such as

exhaustion
dullness
drowsiness
muscle weakness

Section 50565-1

Keep out of the reach of children.

Section 50566-9

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

Section 50567-7

When using this product, use only as directed.

Section 53414-9

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

Warnings

Ask a doctor before use if

you are taking any other medications
you have a medical condition

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.

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)

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.

Structured Label Content

Uses

to temporarily relieve symptoms commonly associated with gout, such as

exhaustion
dullness
drowsiness
muscle weakness

Description (34089-3)

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

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product, use only as directed.

Section 53414-9 (53414-9)

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

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

Warnings

Ask a doctor before use if

you are taking any other medications
you have a medical condition

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 (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 (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? (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.

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)

Active Ingredients (per Dose) (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.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACTAEA SPICATA ROOT", "unii": "3FU86L9OS0", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PHOSPHATE ION", "unii": "NK08V8K8HR", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ATROPA BELLADONNA", "unii": "WQZ3G9PF0H", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "COLCHICUM AUTUMNALE BULB", "unii": "993QHL78E6", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "FORMIC ACID", "unii": "0YIW783RG1", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CARBONATE ION", "unii": "7UJQ5OPE7D", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "unii": "269XH13919", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PHYTOLACCA AMERICANA ROOT", "unii": "11E6VI8VEG", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "RHODODENDRON AUREUM LEAF", "unii": "IV92NQJ73U", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "URTICA URENS", "unii": "IHN2NQ5OF9", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "LEDUM PALUSTRE TWIG", "unii": "877L01IZ0P", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "FRAXINUS EXCELSIOR LEAF", "unii": "RC38362Q7M", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "to temporarily relieve symptoms commonly associated with gout, such as exhaustion dullness drowsiness muscle weakness", "34089-3": "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", "50565-1": "Keep out of the reach of children.", "50566-9": "Stop use and ask a doctor if symptoms persist or worsen.", "50567-7": "When using this product, use only as directed.", "53414-9": "If pregnant or breast-feeding, take only on advice of physician.", "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", "Warnings": "Ask a doctor before use if you are taking any other medications you have a medical condition", "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 info@hellolife.net or call us toll-free at 1.800.875.0850 Monday through Friday, 9am-5pm ET.", "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)", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:49.003657 · Updated: 2026-03-14T23:14:47.176757