GOUTINEX GOUT SYMPTOM RELIEF- actaea spicata, ammonium phosphoricum, belladonna, colchicum autumnale, formicum acidum, fraxinus excelsior, ledum palustre, natrum carbonicum, nux vomica, phytolacca decandra, rhododendron chrysanthum, salicylicum acidum, urtica urens liquid

Goutinex by

Drug Labeling and Warnings

Goutinex by is a Homeopathic medication manufactured, distributed, or labeled by Hello Life, Inc., King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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
  

When using this product, use only as directed.

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

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

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 info@hellolife.net 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)

INGREDIENTS AND APPEARANCE

GOUTINEX  GOUT SYMPTOM RELIEF
actaea spicata, ammonium phosphoricum, belladonna, colchicum autumnale, formicum acidum, fraxinus excelsior, ledum palustre, natrum carbonicum, nux vomica, phytolacca decandra, rhododendron chrysanthum, salicylicum acidum, urtica urens liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49726-023
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0)	ACTAEA SPICATA ROOT	10 [hp_X]  in 59 mL
AMMONIUM PHOSPHATE, DIBASIC (UNII: 10LGE70FSU) (PHOSPHATE ION - UNII:NK08V8K8HR)	AMMONIUM PHOSPHATE, DIBASIC	10 [hp_X]  in 59 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	10 [hp_X]  in 59 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	10 [hp_X]  in 59 mL
FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1)	FORMIC ACID	10 [hp_X]  in 59 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)	SODIUM CARBONATE	10 [hp_X]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	10 [hp_X]  in 59 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	10 [hp_X]  in 59 mL
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	10 [hp_X]  in 59 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 [hp_X]  in 59 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	10 [hp_X]  in 59 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	10 [hp_X]  in 59 mL
FRAXINUS EXCELSIOR LEAF (UNII: RC38362Q7M) (FRAXINUS EXCELSIOR LEAF - UNII:RC38362Q7M)	FRAXINUS EXCELSIOR LEAF	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49726-023-02	1 in 1 CARTON	11/09/2011
1		59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/09/2011

Labeler - Hello Life, Inc. (065619378)

Establishment
Name	Address	ID/FEI	Business Operations
Hello Life, Inc.		065619378	relabel(49726-023) , repack(49726-023)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(49726-023)