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
- NDC Code(s): 75053-0010-1
- Packager: Nucleic Products, LLC
- 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 March 20, 2025
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ACTIVE INGREDIENTS:
Baryta Carbonica 12X , 30C HPUS, Benzinum 9X, 30C HPUS, Berberis Vulgaris 9X HPUS, Eupatorium Perfoliatum 6X HPUS, Gelsemium Sempervirens 30C HPUS, Glandula Suprarenalis Suis 7C HPUS, Hypothalamus Suis 7C HPUS, Hypophysis Suis 7C HPUS, Mentha Pulegium 9X, 6C HPUS, Moschus 9X, 6C HPUS, Natrum Carbonicum 30C HPUS, Nux Vomica 30C HPUS, Pyridoxinum Hydrochloricum 12C HPUS, Sepia 9X, 30C HPUS, Staphysagria 30C HPUS, Thyroidinum 7C HPUS.
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PURPOSE:
Baryta Carbonica – To regulate sweat, Benzinum – To regulate sweat, Berberis Vulgaris – To regulate digestion, Eupatorium Perfoliatum – To regulate thirst response, Gelsemium Sempervirens – For temperature regulation, Glandula Suprarenalis Suis – For adrenal support, Hypothalamus Suis – For hypothalamus support, Hypophysis Suis – For pituitary support, Mentha Pulegium – To regulate digestion, Moschus – To regulate anger, Natrum Carbonicum – For mild headache, Nux Vomica – For biliousness, Pyridoxinum Hydrochloricum – For energy support, Sepia – To regulate smell, Staphysagria – For anger, Thyroidinum – For thyroid support
- USES:
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WARNINGS:
As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if Symptoms persist for more than 7 days or worsen.
Keep this and all medications out of the reach of children
In case of accidental overdose, contact a medical professional or a poison control center immediately.
Do not use if seal is broken or missing.
This product does not contain sugar, starch, preservatives, artificial flavors or additives, and no wheat, gluten , soy, or milk derivatives. - KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INACTIVE INGREDIENTS
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75053-0010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] in 1 mL BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 9 [hp_X] in 1 mL MENTHA PULEGIUM WHOLE (UNII: 5Q6Y7K4846) (MENTHA PULEGIUM WHOLE - UNII:5Q6Y7K4846) MENTHA PULEGIUM WHOLE 9 [hp_X] in 1 mL MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7) (MOSCHUS MOSCHIFERUS MUSK SAC RESIN - UNII:8KFK4W7KP7) MOSCHUS MOSCHIFERUS MUSK SAC RESIN 9 [hp_X] in 1 mL BENZENE (UNII: J64922108F) (BENZENE - UNII:J64922108F) BENZENE 9 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 9 [hp_X] in 1 mL BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE 12 [hp_X] in 1 mL SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND 7 [hp_C] in 1 mL SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT) SUS SCROFA PITUITARY GLAND 7 [hp_C] in 1 mL SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS 7 [hp_C] in 1 mL THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED 7 [hp_C] in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 12 [hp_C] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C] in 1 mL SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 30 [hp_C] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 1 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75053-0010-1 118 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 05/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/11/2021 Labeler - Nucleic Products, LLC (117470417) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(75053-0010) , api manufacture(75053-0010) , label(75053-0010) , pack(75053-0010)