Label: APO-RHEUM- arnica montana root, bryonia dioica root, colchicum autumnale bulb, solanum dulcamara top, pseudognaphalium obtusifolium, guaiacum officinale resin, and taraxacum officinale whole solution/ drops
- NDC Code(s): 59469-134-10
- Packager: PEKANA Naturheilmittel GmbH
- 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 5, 2022
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- Indications
- Dosage
- Warning
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
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INGREDIENTS AND APPEARANCE
APO-RHEUM
arnica montana root, bryonia dioica root, colchicum autumnale bulb, solanum dulcamara top, pseudognaphalium obtusifolium, guaiacum officinale resin, and taraxacum officinale whole solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59469-134 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 12 [hp_X] in 50 mL BRYONIA DIOICA ROOT (UNII: 53UB5FH7CX) (BRYONIA DIOICA ROOT - UNII:53UB5FH7CX) BRYONIA DIOICA ROOT 4 [hp_X] in 50 mL COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB 12 [hp_X] in 50 mL SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 12 [hp_X] in 50 mL PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE 4 [hp_X] in 50 mL GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6) GUAIACUM OFFICINALE RESIN 6 [hp_X] in 50 mL TARAXACUM OFFICINALE WHOLE (UNII: 7C42E2D7B0) (TARAXACUM OFFICINALE WHOLE - UNII:7C42E2D7B0) TARAXACUM OFFICINALE WHOLE 12 [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:59469-134-10 1 in 1 BOX 12/11/2008 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 12/11/2008 Labeler - PEKANA Naturheilmittel GmbH (320344542) Establishment Name Address ID/FEI Business Operations PEKANA Naturheilmittel GmbH 320344542 MANUFACTURE(59469-134)