Label: APO-PULM- onion, bryonia dioica root, hedera helix flowering twig, hyoscyamus niger, phosphorus, polygala senega root, antimony potassium tartrate, and pulmonaria officinalis whole syrup
- NDC Code(s): 59469-101-20, 59469-101-50
- 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 December 5, 2022
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- Indications
- Dosage
- Warning
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 250 ml Bottle Box
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INGREDIENTS AND APPEARANCE
APO-PULM
onion, bryonia dioica root, hedera helix flowering twig, hyoscyamus niger, phosphorus, polygala senega root, antimony potassium tartrate, and pulmonaria officinalis whole syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59469-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H) Onion 4 [hp_X] in 125 mL Bryonia Dioica Root (UNII: 53UB5FH7CX) (Bryonia Dioica Root - UNII:53UB5FH7CX) Bryonia Dioica Root 4 [hp_X] in 125 mL Hedera helix Flowering Twig (UNII: 3D10KUA6BM) (Hedera helix Flowering Twig - UNII:3D10KUA6BM) Hedera helix Flowering Twig 8 [hp_X] in 125 mL Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger 4 [hp_X] in 125 mL Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 10 [hp_X] in 125 mL Polygala senega Root (UNII: M7T6H7D4IF) (Polygala Senega Root - UNII:M7T6H7D4IF) Polygala senega Root 4 [hp_X] in 125 mL Antimony potassium tartrate (UNII: DL6OZ476V3) (Antimony Cation (3+) - UNII:069647RPT5) Antimony potassium tartrate 6 [hp_X] in 125 mL Pulmonaria officinalis Whole (UNII: 483B0A2Y00) (Pulmonaria Officinalis Whole - UNII:483B0A2Y00) Pulmonaria officinalis Whole 4 [hp_X] in 125 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:59469-101-20 1 in 1 BOX 12/11/2008 02/03/2020 1 125 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 2 NDC:59469-101-50 1 in 1 BOX 02/03/2020 2 250 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(59469-101)