Label: HYPOTHALTEM (eupatorium perfoliatum, berberis vulgaris, mentha pulegium, moschus, benzinum, sepia, baryta carbonica, glandula suprarenalis suis, hypophysis suis, hypothalamus suis, thyroidinum- suis, pyridoxinum hydrochloricum, gelsemium sempervirens, natrum carbonicum, nux vomica, staphysagria 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 May 11, 2021

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

  • ACTIVE INGREDIENTS:

    Eupatorium Perfoliatum 6X, Berberis Vulgaris 9X, Mentha Pulegium 9X, 6C, Moschus 9X, 6C, Benzinum 9X, 30C , Sepia 9X, 30C, Baryta Carbonica 12X, 30C, Glandula Suprarenalis Suis 7C, Hypophysis Suis 7C, Hypothalamus Suis 7C, Thyroidinum (Suis) 7C, Pyridoxinum Hydrochloricum 12C, Gelsemium Sempervirens 30C, Natrum Carbonicum 30C, Nux Vomica 30C, Staphysagria 30C.

  • INDICATIONS:

    Homeopathic medicine for the regulation of hypothalamic function.

  • WARNINGS:

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

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

    Do not use if seal is broken or missing.

    This Product does not contain sugar, starch, salt, preservatives, artificial flavors or additives, and no soy or milk derivatives.

  • 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.

  • DIRECTIONS:

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one full dropper up to 2 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    Homeopathic medicine for the regulation of hypothalamic function.

  • INACTIVE INGREDIENTS

    20% ethanol, purified water

  • QUESTIONS:

    Distributed by:
    Nucleic Products, LLC

    PO Box 6856 Grove, OK 74344

  • PACKAGE LABEL DISPLAY:

    NDC: 75053-0010-1

    Nu cleic

    Hypothaltem

    Homeopathic Medicine

    For Professional Use Only

    4 fl oz. (118 ml)

    Hypothaltem

  • INGREDIENTS AND APPEARANCE
    HYPOTHALTEM 
    eupatorium perfoliatum, berberis vulgaris, mentha pulegium, moschus, benzinum, sepia, baryta carbonica, glandula suprarenalis suis, hypophysis suis, hypothalamus suis, thyroidinum (suis), pyridoxinum hydrochloricum, gelsemium sempervirens, natrum carbonicum, nux vomica, staphysagria liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75053-0010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK9 [hp_X]  in 1 mL
    MENTHA PULEGIUM WHOLE (UNII: 5Q6Y7K4846) (MENTHA PULEGIUM WHOLE - UNII:5Q6Y7K4846) MENTHA PULEGIUM WHOLE9 [hp_X]  in 1 mL
    MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7) (MOSCHUS MOSCHIFERUS MUSK SAC RESIN - UNII:8KFK4W7KP7) MOSCHUS MOSCHIFERUS MUSK SAC RESIN9 [hp_X]  in 1 mL
    BENZENE (UNII: J64922108F) (BENZENE - UNII:J64922108F) BENZENE9 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE9 [hp_X]  in 1 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE12 [hp_X]  in 1 mL
    SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND7 [hp_C]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT) SUS SCROFA PITUITARY GLAND7 [hp_C]  in 1 mL
    SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS7 [hp_C]  in 1 mL
    THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED7 [hp_C]  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE12 [hp_C]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_C]  in 1 mL
    SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE30 [hp_C]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]  in 1 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75053-0010-1118 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/11/2021
    Labeler - Nucleic Products, LLC (117470417)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(75053-0010) , api manufacture(75053-0010) , label(75053-0010) , pack(75053-0010)