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 
Hello Life, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts

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

Warnings


Ask a doctor before use if

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


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.


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:

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

GoutinexCarton

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49726-023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA ROOT10 [hp_X]  in 59 mL
AMMONIUM PHOSPHATE, DIBASIC (UNII: 10LGE70FSU) (PHOSPHATE ION - UNII:NK08V8K8HR) AMMONIUM PHOSPHATE, DIBASIC10 [hp_X]  in 59 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 59 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB10 [hp_X]  in 59 mL
FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1) FORMIC ACID10 [hp_X]  in 59 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE10 [hp_X]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 59 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT10 [hp_X]  in 59 mL
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF10 [hp_X]  in 59 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 [hp_X]  in 59 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS10 [hp_X]  in 59 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG10 [hp_X]  in 59 mL
FRAXINUS EXCELSIOR LEAF (UNII: RC38362Q7M) (FRAXINUS EXCELSIOR LEAF - UNII:RC38362Q7M) FRAXINUS EXCELSIOR LEAF10 [hp_X]  in 59 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49726-023-021 in 1 CARTON11/09/2011
159 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/09/2011
Labeler - Hello Life, Inc. (065619378)
Establishment
NameAddressID/FEIBusiness Operations
Hello Life, Inc.065619378relabel(49726-023) , repack(49726-023)
Establishment
NameAddressID/FEIBusiness Operations
King Bio Inc.617901350manufacture(49726-023)

Revised: 12/2018
Document Id: 7df183c1-5f62-1a16-e053-2991aa0a2223
Set id: 4243e27f-ce96-4e73-9948-be88c5d02726
Version: 10
Effective Time: 20181226
 
Hello Life, Inc.