Label: ALLERGEN II (potassium gluconate, adrenalinum, hepar bovine, arsenicum album, phosphorus, pulsatilla- pratensis, sulphur, ambrosia artemisiaefolia, kentucky bluegrass, orchard grass, bermuda grass, johnson grass, rye grass, vernal grass, bahia grass, timothy grass, histaminum hydrochloricum liquid
- NDC Code(s): 43857-0557-1
- Packager: BioActive Nutritional, Inc.
- 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 June 5, 2023
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ACTIVE INGREDIENTS:
Potassium Gluconate 6X, Adrenalinum 8X, Hepar Bovine 8X, Arsenicum Album 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Sulphur 12X, Ambrosia Artemisiaefolia 16X, 24X, 30X, Kentucky Bluegrass 16X, 24X, 30X, Orchard Grass 16X, 24X, 30X, Bermuda Grass 16X, 24X, 30X , Johnson Grass 16X, 24X, 30X, Rye Grass 16X, 24X, 30X, Vernal Grass 16X, 24X, 30X, Bahia Grass 16X, 24X, 30X, Timothy Grass 16X, 24X, 30X, Histaminum Hydrochloricum 30X.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ALLERGEN II
potassium gluconate, adrenalinum, hepar bovine, arsenicum album, phosphorus, pulsatilla (pratensis), sulphur, ambrosia artemisiaefolia, kentucky bluegrass, orchard grass, bermuda grass, johnson grass, rye grass, vernal grass, bahia grass, timothy grass, histaminum hydrochloricum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0557 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM GLUCONATE (UNII: 12H3K5QKN9) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM GLUCONATE 6 [hp_X] in 1 mL EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE 8 [hp_X] in 1 mL BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER 8 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE 12 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL AMBROSIA ARTEMISIIFOLIA WHOLE (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA WHOLE 16 [hp_X] in 1 mL POA PRATENSIS TOP (UNII: 7EA48700V9) (POA PRATENSIS TOP - UNII:7EA48700V9) POA PRATENSIS TOP 16 [hp_X] in 1 mL DACTYLIS GLOMERATA TOP (UNII: J41552QKAK) (DACTYLIS GLOMERATA TOP - UNII:J41552QKAK) DACTYLIS GLOMERATA TOP 16 [hp_X] in 1 mL CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON WHOLE - UNII:2Q8MR21NHK) CYNODON DACTYLON POLLEN 16 [hp_X] in 1 mL SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 16 [hp_X] in 1 mL LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (LOLIUM PERENNE POLLEN - UNII:4T81LB52R0) LOLIUM PERENNE POLLEN 16 [hp_X] in 1 mL ANTHOXANTHUM ODORATUM (UNII: YMW1K70E4Q) (ANTHOXANTHUM ODORATUM - UNII:YMW1K70E4Q) ANTHOXANTHUM ODORATUM 16 [hp_X] in 1 mL PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 16 [hp_X] in 1 mL PHLEUM PRATENSE TOP (UNII: S7PW24BX20) (PHLEUM PRATENSE TOP - UNII:S7PW24BX20) PHLEUM PRATENSE TOP 16 [hp_X] in 1 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 30 [hp_X] in 1 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:43857-0557-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/30/2020 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0557) , api manufacture(43857-0557) , label(43857-0557) , pack(43857-0557)