Label: APO-DOLOR- aconitum napellus, semecarpus anacardium fruit, bryonia dioica root, gelsemium sempervirens root, menyanthes trifoliata, piper methysticum root, schoenocaulon officinale seed, and spigelia anthelmia solution/ drops
- NDC Code(s): 59469-130-10
- 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 2, 2022
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- Indications
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- Warning
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
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INGREDIENTS AND APPEARANCE
APO-DOLOR
aconitum napellus, semecarpus anacardium fruit, bryonia dioica root, gelsemium sempervirens root, menyanthes trifoliata, piper methysticum root, schoenocaulon officinale seed, and spigelia anthelmia solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59469-130 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 12 [hp_X] in 50 mL Semecarpus anacardium Fruit (UNII: 7399B063X9) (Semecarpus anacardium Fruit - UNII:7399B063X9) Semecarpus anacardium Fruit 6 [hp_X] in 50 mL Bryonia Dioica Root (UNII: 53UB5FH7CX) (Bryonia Dioica Root - UNII:53UB5FH7CX) Bryonia Dioica Root 3 [hp_X] in 50 mL Gelsemium sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium sempervirens Root - UNII:639KR60Q1Q) Gelsemium sempervirens Root 4 [hp_X] in 50 mL MENYANTHES TRIFOLIATA WHOLE (UNII: 7H0QTZ446K) (MENYANTHES TRIFOLIATA WHOLE - UNII:7H0QTZ446K) MENYANTHES TRIFOLIATA WHOLE 3 [hp_X] in 50 mL Macropiper Methysticum Root (UNII: BOW48C81XP) (Macropiper Methysticum Root - UNII:BOW48C81XP) Macropiper Methysticum Root 8 [hp_X] in 50 mL Schoenocaulon officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon officinale Seed 3 [hp_X] in 50 mL SPIGELIA ANTHELMIA WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA WHOLE - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE 3 [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:59469-130-10 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(59469-130)