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
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- 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 May 11, 2021
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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:
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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.
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- INACTIVE INGREDIENTS
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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)
