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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 August 29, 2014

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  • DOSAGE & ADMINISTRATION

    Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

    Adult Dose: 3 Pump Sprays

    Child's Dose (2-12): 2 Pump Sprays

    Infants - 2 yrs. 1 Pump Spray

  • WARNINGS

    Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Other information: Tamper resistant for your protection. Use only if safety seal is intact.

  • PURPOSE

    Indications: for temporary relief of pain in the:

    • great toe
    • heel
    • foot
    • joints

    Including:

    • swelling
    • burning
    • itching
    • tingling
    • tearing pains
    • throbbing
    • cramps
    • shooting pains
  • ACTIVE INGREDIENT

    Active Ingredients: Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, urtica urens. ​Equal volumes of each ingredient in 10X, 30X, 100X potencies.

  • INACTIVE INGREDIENT

    Inactive Ingredient: Citric acid, potassium sorbate, purified water.

  • INDICATIONS & USAGE

    Indications: For temporary relief of pain in the:

    • great toe
    • heel
    • foot
    • joints

    Including:

    • swelling
    • burning
    • itching
    • tingling
    • tearing pains
    • throbbing
    • cramps
    • shooting pains
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GOUT SYMPTOM RELIEVER 
    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:66579-0057
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66579-0057-229 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/29/2014
    Labeler - New Sun Inc. (957251176)
    Registrant - New Sun Inc. (957251176)
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