Label: ALLER-DETOX CAFFEINE- adrenalinum, caffeinum, chamomilla, coffea cruda, coffea tosta, ephedra vulgaris, ferrum metallicum, ilex paraguariensis, kali phosphoricum, kali phosphoricum, paullinia sorbilis, saccharum officinale, sterculia acuminata, sulphuricum acidum, thea sinensis 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 21, 2013

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  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________________

    HPUS active ingredients: Adrenalinum, Caffeinum, Chamomilla, Coffea tosta, Ephedra vulgaris, Ferrum metallicum, Ilex paraguariensis, Kali phosphoricum, Paullinia sorbilis, Saccharum officinale, Sterculia acuminata, Sulphuricum acidum, Thea sinensis. Equal volumes of each ingredient in 12X, 24X, 30C, LM1, LM2, LM3, LM5 potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of symptoms of caffeine allergy, sensitivity or withdrawal: mood changes, hyperactivity, irritability, weak memory and concentration, anxiety, headaches, fatigue, muscle pain.

  • INACTIVE INGREDIENT

    Inactive ingredients: Bio-Energetically Enhanced pure water, 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 12 and up 3 sprays 3 times per day.
    • Children 2-12- 2 sprays 3 times per day.
    • Children 2 mo.-2yr.- 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 independently tested.

  • PURPOSE

    Uses for temporary relief of symptoms of caffeine allergy, sensitivity or withdrawal:

    • mood changes
    • hyperactivity
    • irritability
    • weak memory and concentration
    • anxiety
    • headaches
    • fatigue
    • muscle pain
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALLER-DETOX CAFFEINE 
    adrenalinum, caffeinum, chamomilla, coffea cruda, coffea tosta, ephedra vulgaris, ferrum metallicum, ilex paraguariensis, kali phosphoricum, kali phosphoricum, paullinia sorbilis, saccharum officinale, sterculia acuminata, sulphuricum acidum, thea sinensis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-2409
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE12 [hp_X]  in 59 mL
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE12 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA12 [hp_X]  in 59 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN12 [hp_X]  in 59 mL
    COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED12 [hp_X]  in 59 mL
    EPHEDRA DISTACHYA FLOWERING TWIG (UNII: R55VQ87DP3) (EPHEDRA DISTACHYA FLOWERING TWIG - UNII:R55VQ87DP3) EPHEDRA DISTACHYA FLOWERING TWIG12 [hp_X]  in 59 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON12 [hp_X]  in 59 mL
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) (ILEX PARAGUARIENSIS LEAF - UNII:1Q953B4O4F) ILEX PARAGUARIENSIS LEAF12 [hp_X]  in 59 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC12 [hp_X]  in 59 mL
    PAULLINIA CUPANA SEED (UNII: C21GE7524R) (PAULLINIA CUPANA SEED - UNII:C21GE7524R) PAULLINIA CUPANA SEED12 [hp_X]  in 59 mL
    SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE12 [hp_X]  in 59 mL
    COLA ACUMINATA SEED (UNII: 1F8VIW1479) (COLA ACUMINATA SEED - UNII:1F8VIW1479) COLA ACUMINATA SEED12 [hp_X]  in 59 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID12 [hp_X]  in 59 mL
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF12 [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:57955-2409-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/21/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-2409)
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