Label: HYPOTHALMUS TINCTURE- aralia quinquefolia, hydrocotyle asiatica, polygonum multiflorum, hypothalamus, pituitarum posterium, germanium sesquioxide, pineal, 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 22, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Aralia quinquefolia 3X, Hydrocotyle asiatica 3X, Polygonum multiflorum 3X, Hypothalamus 8X, Pituitarum posterium 8X, Germanium sesquioxide 12X, Pineal 14X.

  • PURPOSE

    INDICATIONS:  Provides a specific sarcode support for the hypothalamus-pituitary-pineal axis.  Gives temporary relief of weakness, exhaustion, vertigo and difficult mental concentration.

  • WARNINGS

    WARNINGS:  Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding, ask a health professional before use.

    Do not use if tamper evident seal is broken or missing.


  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.


  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.


  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.   In case of overdose, get medical help or contact a Poison Control Center right away.


  • INDICATIONS & USAGE

    INDICATIONS:  Provides a specific sarcode support for the hypothalamus-pituitary-pineal axis.  Gives temporary relief of weakness, exhaustion, vertigo, and difficult mental concentration.

  • QUESTIONS

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC 29322



  • PRINCIPAL DISPLAY PANEL

    Synergy Formulas

    HYPOTHALAMUS TINCTURE

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Hypothalamus Tincture

  • INGREDIENTS AND APPEARANCE
    HYPOTHALMUS TINCTURE 
    aralia quinquefolia, hydrocotyle asiatica, polygonum multiflorum, hypothalamus, pituitarum posterium, germanium sesquioxide, pineal, liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0288
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG3 [hp_X]  in 1 mL
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA3 [hp_X]  in 1 mL
    SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS8 [hp_X]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND8 [hp_X]  in 1 mL
    GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE12 [hp_X]  in 1 mL
    SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7) SUS SCROFA PINEAL GLAND14 [hp_X]  in 1 mL
    FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC) (FALLOPIA MULTIFLORA ROOT - UNII:AUZ3VD75MC) FALLOPIA MULTIFLORA ROOT 3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0288-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/28/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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