Label: EMVITA 8- ammonium carbonate, graphite, quinine arsenite, opium, and oyster shell calcium carbonate, crude liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 66343-020-50 - Packager: RUBIMED AG
- 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, 2015
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- PURPOSE
- Ingredients
- TAMPER-EVIDENT
- Directions
- Warnings
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
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INGREDIENTS AND APPEARANCE
EMVITA 8
ammonium carbonate, graphite, quinine arsenite, opium, and oyster shell calcium carbonate, crude liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66343-020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ammonium carbonate (UNII: NJ5VT0FKLJ) (Ammonium cation - UNII:54S68520I4, Carbonate ion - UNII:7UJQ5OPE7D) Ammonium carbonate 800 [hp_C] in 1 mL Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite 16 [hp_M] in 1 mL Quinine arsenite (UNII: 42QO5P0NLM) (Quinine - UNII:A7V27PHC7A, Arsenite ion - UNII:N5509X556J) Quinine arsenite 18 [hp_M] in 1 mL Opium (UNII: 37M3MZ001L) (Opium - UNII:37M3MZ001L) Opium 21 [hp_X] in 1 mL Oyster shell calcium carbonate, crude (UNII: 2E32821G6I) (Oyster shell calcium carbonate, crude - UNII:2E32821G6I) Oyster shell calcium carbonate, crude 21 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) 0.4 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66343-020-50 50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 05/07/2015 Labeler - RUBIMED AG (480582035) Establishment Name Address ID/FEI Business Operations RUBIMED AG 480582035 MANUFACTURE(66343-020) Establishment Name Address ID/FEI Business Operations Omida AG 483268348 MANUFACTURE(66343-020)