Label: RELAX- histaminum hydrochloricum, dopamine, kidney, l-theanine, penylethylamine hydrochloricum, spray

  • 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 February 14, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Histaminum hydrochloricum 6C, Dopamine 12C, Kidney 12C, L-Theanine 12C, Phenylethylamine hydrochloricum 24C.


  • PURPOSE

    INDICATIONS:  For temporary relief of stress and tension.

  • WARNINGS

    WARNINGS:  Keep out of reach of children.  In case of overdose, contact physician or Poison Control Center right away.

    If pregnant or breast-feeding, seek advice of a health professional before use.

    Tamper seal: "Sealed for Your Protection."  Do not use if seal is broken or missing.  Store in a cool, dry place.



  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  2 sprays under tongue three times daily between meals.  Consult a physician for use in children under 12 years of age.


  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, 20% Ethanol.


  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.  in case of overdose, contact physician or contact Poison Control Center right away.


  • INDICATIONS & USAGE

    INDICATIONS:  For temporary relief of stress and tension.


  • QUESTIONS


    Manufactured for:

    Health and Beyond

    7050 W Palmetto Park rd #15-554

    Boca Raton, FL 33433


  • PRINCIPAL DISPLAY PANEL

    Dr. Larry"s

    RELAX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Relax

  • INGREDIENTS AND APPEARANCE
    RELAX 
    histaminum hydrochloricum, dopamine, kidney, l-theanine, penylethylamine hydrochloricum, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0385
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE6 [hp_C]  in 1 mL
    DOPAMINE (UNII: VTD58H1Z2X) (DOPAMINE - UNII:VTD58H1Z2X) DOPAMINE12 [hp_C]  in 1 mL
    PORK KIDNEY (UNII: X7BCI5P86H) (PORK KIDNEY - UNII:X7BCI5P86H) PORK KIDNEY12 [hp_C]  in 1 mL
    THEANINE (UNII: 8021PR16QO) (THEANINE - UNII:8021PR16QO) THEANINE12 [hp_C]  in 1 mL
    PHENETHYLAMINE HYDROCHLORIDE (UNII: VOF61XW69D) (PHENETHYLAMINE - UNII:327C7L2BXQ) PHENETHYLAMINE HYDROCHLORIDE24 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0385-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/30/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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