Label: BURNOUT- alfalfa, ambra grisea, anacardium orientale, argentum nitricum, aurum metallicum, avena sativa, caladium seguinum, calcarea carbonica, cocculus indicus, gelsemium sempervirens, ignatia amara, kali phosphoricum, lycopodium clavatum, natrum muriaticum, nux vomica, phosphoricum acidum, phosphorus, selenium metallicum, sepia, silicea, sulphur 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 November 13, 2013

If you are a consumer or patient please visit this version.

  • 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

    • 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 (1 month-2 years): 1 spray 3 times per day.
  • OTHER SAFETY INFORMATION

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

  • ACTIVE INGREDIENT

    HPUS active ingredients: Alfalfa, Ambra grisea, Anacardium orientale, Argentum nitricum, Aurum metallicum, Avena sativa, Caladium seguinum, Calcarea carbonica, Cocculus indicus, Gelsemium sempervirens, Ignatia amara, Kali phosphoricum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Phosphorus, Selenium metallicum, Sepia, Silicea, Sulphur. Equal volumes of each ingredient in 10X, 30X, 100X, LM1, LM2, LM3, LM5 potencies.

  • PURPOSE

    Uses temporarily relieves symptoms due to fatigue: headaches, drowsiness, inability to fall asleep, sweet food cravings, sudden drain of energy, nausea.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • INDICATIONS & USAGE

    Uses temporarily relieves symptoms due to fatigue:

    • headaches
    • drowsiness
    • inability to fall asleep
    • sweet food cravings
    • sudden drain of energy
    • nausea
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BURNOUT 
    alfalfa, ambra grisea, anacardium orientale, argentum nitricum, aurum metallicum, avena sativa, caladium seguinum, calcarea carbonica, cocculus indicus, gelsemium sempervirens, ignatia amara, kali phosphoricum, lycopodium clavatum, natrum muriaticum, nux vomica, phosphoricum acidum, phosphorus, selenium metallicum, sepia, silicea, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0980
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA10 [hp_X]  in 59 mL
    AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C) AMBERGRIS10 [hp_X]  in 59 mL
    SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE10 [hp_X]  in 59 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]  in 59 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD10 [hp_X]  in 59 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]  in 59 mL
    DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE10 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 59 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED10 [hp_X]  in 59 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 59 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE10 [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
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 59 mL
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM10 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0980-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/09/2013
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-0980)