Goutflex Gout Symptom Formula

Goutflex Gout Symptom Formula
SPL v1
SPL
SPL Set ID d1866562-7d0a-4129-9640-f024e7645432
Route
ORAL
Published
Effective Date 2015-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphate Ion (10 [hp_X]) Atropa Belladonna Colchicum Autumnale Bulb Formic Acid Fraxinus Excelsior Bark Fraxinus Excelsior Leaf Ledum Palustre Twig Carbonate Ion Strychnos Nux-vomica Seed Urtica Urens
Inactive Ingredients
Anhydrous Citric Acid Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-09-28

Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients                                                                            Purpose † Equal volumes of each ingredient in 10X, 30X and LM1 potencies. Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens.


Medication Information

Warnings and Precautions

Warnings

  • If symptoms persist or worsen, seek advice of a physician.
  • If pregnant or breast-feeding, ask a healthcare professional before use.
Indications and Usage

Uses for temporary relief of symptoms in toes, heels, feet, or joints: • discomforts • cramping • tender or itchy joints.

Dosage and Administration

Directions

Initially, depress pump until primed. Spray one dose directly into mouth. Adults: 4 sprays 2 times per day. (approximately every 12 hours) Use additionally as needed, up to 3 times per day.

Description

Drug Facts ​__________________________________________________________________________________________________________ HPUS active ingredients                                                                            Purpose † Equal volumes of each ingredient in 10X, 30X and LM1 potencies. Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

Inactive Ingredients:

Citric acid, potassium sorbate, pure water.

Section 51945-4

Section 55105-1

Drug Facts

__________________________________________________________________________________________________________

HPUS active ingredients                                             Purpose †

Equal volumes of each ingredient in 10X, 30X and LM1 potencies.

Ammonium phosphoricum...........................inflammation of joints

Belladonna.................................................red and tender joints

Colchicum autumnale......................................sensitivity to touch

Formicum acidum...............................................joint discomfort

Fraxinus excelsior...................................foot-related discomforts

Ledum palustre...................................swelling of joints and toes

Natrum carbonicum...............................................tender joints

Nux vomica..................................................................itching

Urtica urens.....................................................joint discomfort

Section 55106-9

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients                                                                            Purpose †

Equal volumes of each ingredient in 10X, 30X and LM1 potencies.

Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens.

Section 60561-8

Other Information: This product is intended to complement, not replace, standard medical care.

This product has not been clinically tested. Homeopathic provings for each HPUS ingredient are found in various materia medicas referenced in the FDA Compliance Policy Guide.

Manufactured for: Nutra Vista Health, LLC. 3632 Land O Lakes Blvd 106-14 Land O Lakes, FL, 34639 Questions? Call 813.926.7903 www.goutflex.com


Structured Label Content

Indications and Usage (34067-9)

Uses for temporary relief of symptoms in toes, heels, feet, or joints: • discomforts • cramping • tender or itchy joints.

Dosage and Administration (34068-7)

Directions

Initially, depress pump until primed. Spray one dose directly into mouth. Adults: 4 sprays 2 times per day. (approximately every 12 hours) Use additionally as needed, up to 3 times per day.

Warnings and Precautions (34071-1)

Warnings

  • If symptoms persist or worsen, seek advice of a physician.
  • If pregnant or breast-feeding, ask a healthcare professional before use.
Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

Inactive Ingredients:

Citric acid, potassium sorbate, pure water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Drug Facts

__________________________________________________________________________________________________________

HPUS active ingredients                                             Purpose †

Equal volumes of each ingredient in 10X, 30X and LM1 potencies.

Ammonium phosphoricum...........................inflammation of joints

Belladonna.................................................red and tender joints

Colchicum autumnale......................................sensitivity to touch

Formicum acidum...............................................joint discomfort

Fraxinus excelsior...................................foot-related discomforts

Ledum palustre...................................swelling of joints and toes

Natrum carbonicum...............................................tender joints

Nux vomica..................................................................itching

Urtica urens.....................................................joint discomfort

Section 55106-9 (55106-9)

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients                                                                            Purpose †

Equal volumes of each ingredient in 10X, 30X and LM1 potencies.

Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens.

Section 60561-8 (60561-8)

Other Information: This product is intended to complement, not replace, standard medical care.

This product has not been clinically tested. Homeopathic provings for each HPUS ingredient are found in various materia medicas referenced in the FDA Compliance Policy Guide.

Manufactured for: Nutra Vista Health, LLC. 3632 Land O Lakes Blvd 106-14 Land O Lakes, FL, 34639 Questions? Call 813.926.7903 www.goutflex.com


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