Label: APO-TUSS- arum maculatum root, bryonia dioica root, protortonia cacti, cupric acetate, gelsemium sempervirens root, hedera helix flowering twig, lactuca virosa, and horseradish solution/ drops
- NDC Code(s): 59469-104-10
- 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 6, 2022
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- Indications
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
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INGREDIENTS AND APPEARANCE
APO-TUSS
arum maculatum root, bryonia dioica root, protortonia cacti, cupric acetate, gelsemium sempervirens root, hedera helix flowering twig, lactuca virosa, and horseradish solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59469-104 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Arum Maculatum Root (UNII: 646O39K8BJ) (Arum Maculatum Root - UNII:646O39K8BJ) Arum Maculatum Root 4 [hp_X] in 50 mL Bryonia Dioica Root (UNII: 53UB5FH7CX) (Bryonia Dioica Root - UNII:53UB5FH7CX) Bryonia Dioica Root 4 [hp_X] in 50 mL Protortonia Cacti (UNII: LZB7TFX1LT) (Protortonia Cacti - UNII:LZB7TFX1LT) Protortonia Cacti 2 [hp_X] in 50 mL Cupric Acetate (UNII: 39M11XPH03) (Cupric Cation - UNII:8CBV67279L) Cupric Acetate 4 [hp_X] in 50 mL Gelsemium sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium sempervirens Root 4 [hp_X] in 50 mL Hedera helix Flowering Twig (UNII: 3D10KUA6BM) (Hedera helix Flowering Twig - UNII:3D10KUA6BM) Hedera helix Flowering Twig 6 [hp_X] in 50 mL LACTUCA VIROSA WHOLE (UNII: 6D74QW4H67) (LACTUCA VIROSA WHOLE - UNII:6D74QW4H67) LACTUCA VIROSA WHOLE 4 [hp_X] in 50 mL Horseradish (UNII: 8DS6G120HJ) (Horseradish - UNII:8DS6G120HJ) Horseradish 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:59469-104-10 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(59469-104)