Label: GOUTFLEX GOUT SYMPTOM FORMULA- ammonium phosphoricum, belladonna, colchicum autumnale, formicum acidum, fraxinus excelsior, ledum palustre, natrum carbonicum, nux vomica, urtica urens liquid

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated September 29, 2015

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    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.

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

    • If symptoms persist or worsen, seek advice of a physician.
    • If pregnant or breast-feeding, ask a healthcare professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & 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.

  • OTHER SAFETY INFORMATION

    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

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Citric acid, potassium sorbate, pure water.

  • PURPOSE

    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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GOUTFLEX GOUT SYMPTOM FORMULA 
    ammonium phosphoricum, belladonna, colchicum autumnale, formicum acidum, fraxinus excelsior, ledum palustre, natrum carbonicum, nux vomica, urtica urens liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69760-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    FRAXINUS EXCELSIOR BARK (UNII: R6KCX5H8I2) (FRAXINUS EXCELSIOR BARK - UNII:R6KCX5H8I2) FRAXINUS EXCELSIOR BARK10 [hp_X]  in 59 mL
    FRAXINUS EXCELSIOR LEAF (UNII: RC38362Q7M) (FRAXINUS EXCELSIOR LEAF - UNII:RC38362Q7M) FRAXINUS EXCELSIOR LEAF10 [hp_X]  in 59 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG10 [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
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69760-0001-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/28/2015
    Labeler - Nutra Vista Health LLC. (079775793)
    Registrant - Nutra Vista Health LLC. (079775793)