Label: ALLER-DETOX FOOD ADDITIVES AND PRESERVATIVES- formicum acidum, gambogia, natrum bicarbonicum, natrum nitricum, natrum nitrosum, natrum sulphuricum, nux vomica, phosphoricum acidum, phytolacca decandra, rosa canina, saccharinum 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 December 20, 2016

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  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________________

    HPUS active ingredients: Formicum acidum, Gambogia, Natrum bicarbonicum, Natrum nitricum, Natrum nitrosum, Natrum sulphuricum, Nux vomica, Phosphoricum acidum, Phytolacca decandra, Rosa canina, Saccharinum. Equal volumes of each ingredient in 12X, 24X, 30C, 1LM, 2LM, 3LM, 5LM potencies.

  • INDICATIONS & USAGE

    Uses for relief of symptoms from food additives and preservatives:

    • gastrointestinal upset
    • hives
    • itching
    • nasal congestions
    • hyperactivity
    • muscle weakness
    • headaches
    • difficulty sleeping
    • irritability
  • INACTIVE INGREDIENT

    Inactive ingredients: Bio-Energetically Enhanced pure water base, citric acid, potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.

  • 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: 3 sprays 3 times per day.
    • Children 2-12 years: 2 sprays 3 times per day.
    • Children 2 mo - 2 yr.: 1 spray 3 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

  • PURPOSE

    Uses a natural aid for: gastrointestinal upset, hives, itching, nasal congestions, hyperactivity, muscle weakness, headaches, difficulty sleeping, irritability.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALLER-DETOX FOOD ADDITIVES AND PRESERVATIVES 
    formicum acidum, gambogia, natrum bicarbonicum, natrum nitricum, natrum nitrosum, natrum sulphuricum, nux vomica, phosphoricum acidum, phytolacca decandra, rosa canina, saccharinum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-2405
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1) FORMIC ACID12 [hp_X]  in 59 mL
    GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE12 [hp_X]  in 59 mL
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE12 [hp_X]  in 59 mL
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ) (NITRATE ION - UNII:T93E9Y2844) SODIUM NITRATE12 [hp_X]  in 59 mL
    SODIUM NITRITE (UNII: M0KG633D4F) (NITRITE ION - UNII:J39976L608) SODIUM NITRITE12 [hp_X]  in 59 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE12 [hp_X]  in 59 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 59 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 59 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT12 [hp_X]  in 59 mL
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3) (ROSA CANINA FRUIT - UNII:3TNW8D08V3) ROSA CANINA FRUIT12 [hp_X]  in 59 mL
    SACCHARIN (UNII: FST467XS7D) (SACCHARIN - UNII:FST467XS7D) SACCHARIN12 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-2405-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/20/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/20/2013
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-2405)
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