Label: METABATONE (aralia racemosa, avena sativa, berberis vulgaris, capsicum annuum, ginkgo biloba, adenosinum triphosphoricum dinatrum, alpha-ketoglutaricum acidum, fel tauri, hyaluronidase, pancreas suis, pancreatinum, papain, stomach- suis, l-alanine, l- arginine, l-carnitine, cysteinum, l-glutamine, l-histidine, l-isoleucine, l-leucine, l-lysine, l-methionine, l-ornithine, l-proline, l-serine, l-tryptophan, l-tyrosine, l-valine, calcarea carbonica, calcarea phosphorica, hepar sulphuris calcareum, lycopodium clavatum, liquid
- NDC Code(s): 44911-0519-1
- Packager: Energique, Inc.
- 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 December 29, 2022
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ACTIVE INGREDIENTS:
(in each drop): 3.01% of alpha-Ketoglutaricum Acidum 9X, 10X, 12X, L-Alanine 12X, L-Arginine 12X, L-Carnitine 12X, Cysteinum 12X, L-Glutamine 12X, L-Histidine 12X, L-Isoleucine 12X, L-Leucine 12X, L-Lysine 12X, L-Methionine 12X, L-Ornithine 12X, L-Proline 12X, L-Serine 12X, L-Tryptophan 12X, L-Tyrosine 12X, L-Valine 12X, Adenosinum Triphosphoricum Dinatrum 9X, 10X, 12X, Bromelain 9C, 10C, 12C, Calcarea Carbonica 12X, Calcarea Phosphorica 12X, Fel Tauri 10X, 12X, Hepar Sulphuris Calcareum 12X, Hyaluronidase 9X, 10X, 12X, Iodium 12X, Lycopodium Clavatum 12X, Magnesia Carbonica 12X, Natrum Muriaticum 12X, Pancreas Suis 9X, 10X, 12X, Pancreatinum 10X, 12X, Papain 9X, 10X, 12X, Stomach (Suis) 9X, 10X, 12X; 0.10% of Aralia Racemosa 3X, Avena Sativa 3X, Berberis Vulgaris 3X, Capsicum Annuum 3X, Fel Tauri 9X, Ginkgo Biloba 3X, Pancreatinum 9X.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
METABATONE
aralia racemosa, avena sativa, berberis vulgaris, capsicum annuum, ginkgo biloba, adenosinum triphosphoricum dinatrum, alpha-ketoglutaricum acidum, fel tauri, hyaluronidase, pancreas suis, pancreatinum, papain, stomach (suis), l-alanine, l- arginine, l-carnitine, cysteinum, l-glutamine, l-histidine, l-isoleucine, l-leucine, l-lysine, l-methionine, l-ornithine, l-proline, l-serine, l-tryptophan, l-tyrosine, l-valine, calcarea carbonica, calcarea phosphorica, hepar sulphuris calcareum, lycopodium clavatum, liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0519 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT 3 [hp_X] in 1 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 3 [hp_X] in 1 mL BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 3 [hp_X] in 1 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 3 [hp_X] in 1 mL GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO 3 [hp_X] in 1 mL ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE DISODIUM 9 [hp_X] in 1 mL OXOGLURIC ACID (UNII: 8ID597Z82X) (.ALPHA.-KETOGLUTARIC ACID - UNII:8ID597Z82X) OXOGLURIC ACID 9 [hp_X] in 1 mL BOS TAURUS BILE (UNII: ET3651ZLOU) (BOS TAURUS BILE - UNII:ET3651ZLOU) BOS TAURUS BILE 9 [hp_X] in 1 mL HYALURONIDASE (UNII: 8KOG53Z5EM) (HYALURONIDASE - UNII:8KOG53Z5EM) HYALURONIDASE 9 [hp_X] in 1 mL SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS 9 [hp_X] in 1 mL PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE 9 [hp_X] in 1 mL PAPAIN (UNII: A236A06Y32) (PAPAIN - UNII:A236A06Y32) PAPAIN 9 [hp_X] in 1 mL SUS SCROFA STOMACH (UNII: T0920P9Z9A) (SUS SCROFA STOMACH - UNII:T0920P9Z9A) SUS SCROFA STOMACH 9 [hp_X] in 1 mL ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE 12 [hp_X] in 1 mL ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE 12 [hp_X] in 1 mL CARNITINE (UNII: S7UI8SM58A) (CARNITINE - UNII:S7UI8SM58A) CARNITINE 12 [hp_X] in 1 mL CYSTEINE (UNII: K848JZ4886) (CYSTEINE - UNII:K848JZ4886) CYSTEINE 12 [hp_X] in 1 mL GLUTAMINE (UNII: 0RH81L854J) (GLUTAMINE - UNII:0RH81L854J) GLUTAMINE 12 [hp_X] in 1 mL HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE 12 [hp_X] in 1 mL ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE 12 [hp_X] in 1 mL LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE 12 [hp_X] in 1 mL LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE 12 [hp_X] in 1 mL METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE 12 [hp_X] in 1 mL ORNITHINE (UNII: E524N2IXA3) (ORNITHINE - UNII:E524N2IXA3) ORNITHINE 12 [hp_X] in 1 mL PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE 12 [hp_X] in 1 mL SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE 12 [hp_X] in 1 mL TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN 12 [hp_X] in 1 mL TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE 12 [hp_X] in 1 mL VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE 12 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 12 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 12 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 12 [hp_X] in 1 mL MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE 12 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 12 [hp_X] in 1 mL BROMELAINS (UNII: U182GP2CF3) (BROMELAINS - UNII:U182GP2CF3) BROMELAINS 9 [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:44911-0519-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/11/2020 03/16/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/11/2020 03/16/2025 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0519) , api manufacture(44911-0519) , label(44911-0519) , pack(44911-0519)