Label: APO-OEDEM- horse chestnut, apocynum cannabinum root, convallaria majalis flowering top, helleborus niger root, thuja occidentalis leafy twig, sambucus nigra flowering top, filipendula ulmaria root, and corn silk solution/ drops
- NDC Code(s): 59469-302-10
- Packager: PEKANA Naturheilmittel Gmbh
- Category: HUMAN OTC DRUG LABEL
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 January 11, 2023
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- Indications
- Dosage
- Warning
- Tamper Evident
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
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INGREDIENTS AND APPEARANCE
APO-OEDEM
horse chestnut, apocynum cannabinum root, convallaria majalis flowering top, helleborus niger root, thuja occidentalis leafy twig, sambucus nigra flowering top, filipendula ulmaria root, and corn silk solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59469-302 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 4 [hp_X] in 50 mL APOCYNUM CANNABINUM ROOT (UNII: 2F92409L9Z) (APOCYNUM CANNABINUM ROOT - UNII:2F92409L9Z) APOCYNUM CANNABINUM ROOT 3 [hp_X] in 50 mL CONVALLARIA MAJALIS FLOWERING TOP (UNII: 4G7VTP9FC4) (CONVALLARIA MAJALIS FLOWERING TOP - UNII:4G7VTP9FC4) CONVALLARIA MAJALIS FLOWERING TOP 12 [hp_X] in 50 mL HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT 4 [hp_X] in 50 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X] in 50 mL SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 4 [hp_X] in 50 mL FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) (FILIPENDULA ULMARIA ROOT - UNII:997724QNDS) FILIPENDULA ULMARIA ROOT 6 [hp_X] in 50 mL CORN SILK (UNII: 7D3VB244UX) (CORN SILK - UNII:7D3VB244UX) CORN SILK 4 [hp_X] in 50 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:59469-302-10 1 in 1 BOX 06/24/2019 1 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 06/24/2019 Labeler - PEKANA Naturheilmittel Gmbh (320344542) Establishment Name Address ID/FEI Business Operations PEKANA Naturheilmittel Gmbh 320344542 MANUFACTURE(59469-302)