Label: STALEAN- l-carnitine tartrate, l-isoleucine, l-leucine, l-valine, magnesia phosphorica, pyridoxine, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 57520-0190-1 - Packager: Apotheca Company
- 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 July 13, 2010
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ACTIVE INGREDIENT
Active Ingredients: L Carnitine Tartrate 30X, 60X, L Isoleucine 30X, 60X, L Leucine 30X, 60X, L Valine 30X, 60X, Magnesia Phosphorica 30X, 60X, Pyridoxine 30X, 60X, Argentum Metallicum 60X, 100X, 200X, Calcarea Carbonica 60X, 100X, 200X, Mercurius Solubilis 60X, 100X, 200X, Natrum Sulphuricum 60X, 100X, 200X, Oleander 60X, 100X, 200X, Sabadilla 60X, 100X, 200X, Hypothalamus 6C, 12C, 30C, 100C, Dopamine 6C, 60C, 100C, 200C, Pancreas 6C, 60C, 100C, 200C, Serotonin 6C. 60C, 100C, 200C, Spleen 6C, 60C, 100C, 200C.
- PURPOSE
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WARNINGS
WARNINGS: As with any drug,if pregnant or breast-feeding; or under age 18; consult a physician before use. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken. Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.
Store in a cool, dry place after opening.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STALEAN
l-carnitine tartrate, l-isoleucine, l-leucine, l-valine, magnesia phosphorica, pyridoxine, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57520-0190 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 60 [hp_X] in 1 mL PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 60 [hp_X] in 1 mL SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 200 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 200 [hp_X] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 200 [hp_X] in 1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM SULFATE 200 [hp_X] in 1 mL NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) (NERIUM OLEANDER LEAF - UNII:7KV510R6H6) NERIUM OLEANDER LEAF 200 [hp_X] in 1 mL SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 200 [hp_X] in 1 mL SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS 100 [hp_C] in 1 mL DOPAMINE (UNII: VTD58H1Z2X) (DOPAMINE - UNII:VTD58H1Z2X) DOPAMINE 200 [hp_C] in 1 mL SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS 200 [hp_C] in 1 mL SEROTONIN (UNII: 333DO1RDJY) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN 200 [hp_C] in 1 mL SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN 200 [hp_C] in 1 mL LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE 60 [hp_X] in 1 mL VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE 60 [hp_X] in 1 mL ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE 60 [hp_X] in 1 mL LEVOCARNITINE TARTRATE (UNII: 4D8F2Q45LQ) (LEVOCARNITINE - UNII:0G389FZZ9M) LEVOCARNITINE TARTRATE 60 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) AVENA SATIVA POLLEN (UNII: A7IKY24TR7) CERATOSTIGMA WILLMOTTIANUM FLOWER (UNII: TP69J995TW) LARIX DECIDUA FLOWERING TOP (UNII: 9UMZ642257) JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG) ULEX EUROPAEUS (UNII: 398DBS1PXN) AESCULUS CARNEA FLOWER (UNII: 717DPT98VM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57520-0190-1 30 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2010 Labeler - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture