Label: ALLERGEN I- potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, peanut, black walnut, juglans regia, almond, cashew, coconut, pecan, brazil nut, lycopersicum esculentum, potato, black pepper, eggplant, gossypium herbaceum, flax, parmesan cheese, milk, beef, lamb, pork, chicken, egg, beans, allium cepa, malus pumila, flos, triticum aestivum, banana, fragaria vesca, citrus sinensis, cod, tuna, salmon, limulus, oyster, shrimp, cortisone aceticum liquid
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- NDC Code(s): 43857-0241-1
- Packager: BioActive Nutritional
- 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 March 31, 2017
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- ACTIVE INGREDIENTS:
Potassium Gluconate 6X, Glandula Suprarenalis Bovine 8X, Hepar Bovine 8X, Arsenicum Album 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X, Peanut 12X, 30X, Black Walnut12X, 30X, Juglans Regia 12X, 30X, Almond 12X, 30X, Cashew 12X, 30X, Coconut 12X, 30X, Pecan 12X, 30X, Brazil Nut 12X, 30X, Lycopersicum Esculentum 12X, 30X, Potato 12X, 30X, Black Pepper 12X, 30X, Eggplant 12X, 30X, Gossypium Herbaceum 12X, 30X, Flax 12X, 30X, Parmesan Cheese 12X, 30X, Milk 12X, 30X, Beef 12X, 30X, Lamb 12X, 30X, Pork 12X, 30X, Chicken 12X, 30X, Egg 12X, 30X, Beans 12X, 30X, Allium Cepa 12X, 30X, Malus Pumila, Flos 12X, 30X, Triticum Aestivum 12X, 30X, Banana 12X, 30X, Fragaria Vesca 12X, 30X, Citrus Sinensis 12X, 30X, Cod 12X, 30X, Tuna 12X, 30X, Salmon 12X, 30X, Limulus 12X, 30X, Oyster 12X, 30X, Shrimp 12X, 30X, Cortisone Aceticum 30X, Histaminum Hydrochloricum 30X, Hyaluronidase 30X, Interferon (Suis) 30X, Serotonin (Hydrochloride) 30X.
Close - INDICATIONS:
For temporary relief of gastrointestinal dyspepsia with flatulence and bloating, loss of weight and intolerance of certain foods.
Close - WARNINGS:
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place.
Close - KEEP OUT OF REACH OF CHILDREN:
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Close - DIRECTIONS:
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Close - INDICATIONS:
For temporary relief of gastrointestinal dyspepsia with flatulence and bloating, loss of weight and intolerance of certain foods.
Close - INACTIVE INGREDIENTS:
- QUESTIONS:
Distributed by:
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BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com - PACKAGE LABEL DISPLAY:
- INGREDIENTS AND APPEARANCE
ALLERGEN I
potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, peanut, black walnut, juglans regia, almond, cashew, coconut, pecan, brazil nut, lycopersicum esculentum, potato, black pepper, eggplant, gossypium herbaceum, flax, parmesan cheese, milk, beef, lamb, pork, chicken, egg, beans, allium cepa, malus pumila, flos, triticum aestivum, banana, fragaria vesca, citrus sinensis, cod, tuna, salmon, limulus, oyster, shrimp, cortisone aceticum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0241 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 BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29) BOS TAURUS ADRENAL GLAND 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 LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 12 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL PEANUT (UNII: QE1QX6B99R) (PEANUT - UNII:QE1QX6B99R) PEANUT 12 [hp_X] in 1 mL BLACK WALNUT (UNII: 02WM57RXZJ) (BLACK WALNUT - UNII:02WM57RXZJ) BLACK WALNUT 12 [hp_X] in 1 mL ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT 12 [hp_X] in 1 mL ALMOND (UNII: 3Z252A2K9G) (ALMOND - UNII:3Z252A2K9G) ALMOND 12 [hp_X] in 1 mL CASHEW (UNII: 3H5U5CX7KO) (CASHEW - UNII:3H5U5CX7KO) CASHEW 12 [hp_X] in 1 mL COCONUT (UNII: 3RT3536DHY) (COCONUT - UNII:3RT3536DHY) COCONUT 12 [hp_X] in 1 mL PECAN (UNII: F14P91GB5F) (PECAN - UNII:F14P91GB5F) PECAN 12 [hp_X] in 1 mL BRAZIL NUT (UNII: XKR79OET1K) (BRAZIL NUT - UNII:XKR79OET1K) BRAZIL NUT 12 [hp_X] in 1 mL SOLANUM LYCOPERSICUM (UNII: 0243Q4990L) (SOLANUM LYCOPERSICUM - UNII:0243Q4990L) SOLANUM LYCOPERSICUM 12 [hp_X] in 1 mL POTATO (UNII: CFE1S8DYWD) (POTATO - UNII:CFE1S8DYWD) POTATO 12 [hp_X] in 1 mL BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER 12 [hp_X] in 1 mL EGGPLANT (UNII: W5K7RAS4VK) (EGGPLANT - UNII:W5K7RAS4VK) EGGPLANT 12 [hp_X] in 1 mL LEVANT COTTON SEED (UNII: 550E4N439V) (LEVANT COTTON SEED - UNII:550E4N439V) LEVANT COTTON SEED 12 [hp_X] in 1 mL FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C) FLAX SEED 12 [hp_X] in 1 mL SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR) SESAME SEED 12 [hp_X] in 1 mL CASEIN, LACTOCOCCUS LACTIS CULTURED (UNII: 489F5JNV5B) (CASEIN, LACTOCOCCUS LACTIS CULTURED - UNII:489F5JNV5B) CASEIN, LACTOCOCCUS LACTIS CULTURED 12 [hp_X] in 1 mL COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK 12 [hp_X] in 1 mL BEEF (UNII: 4PIB2155QP) (BEEF - UNII:4PIB2155QP) BEEF 12 [hp_X] in 1 mL LAMB (UNII: FOF26T73HA) (LAMB - UNII:FOF26T73HA) LAMB 12 [hp_X] in 1 mL PORK (UNII: O138UB266J) (PORK - UNII:O138UB266J) PORK 12 [hp_X] in 1 mL CHICKEN (UNII: 0X8Q245Y7B) (CHICKEN - UNII:0X8Q245Y7B) CHICKEN 12 [hp_X] in 1 mL EGG (UNII: 291P45F896) (EGG - UNII:291P45F896) EGG 12 [hp_X] in 1 mL KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO) KIDNEY BEAN 12 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 12 [hp_X] in 1 mL MALUS PUMILA FLOWER (UNII: EF626V855K) (MALUS DOMESTICA FLOWER - UNII:EF626V855K) MALUS PUMILA FLOWER 12 [hp_X] in 1 mL WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT 12 [hp_X] in 1 mL BANANA (UNII: 4AJZ4765R9) (BANANA - UNII:4AJZ4765R9) BANANA 12 [hp_X] in 1 mL ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY 12 [hp_X] in 1 mL ORANGE (UNII: 5EVU04N5QU) (ORANGE - UNII:5EVU04N5QU) ORANGE 12 [hp_X] in 1 mL COD, UNSPECIFIED (UNII: 8D6Q5LNG3D) (COD, UNSPECIFIED - UNII:8D6Q5LNG3D) COD, UNSPECIFIED 12 [hp_X] in 1 mL TUNA, UNSPECIFIED (UNII: V2T3IHT3E2) (TUNA, UNSPECIFIED - UNII:V2T3IHT3E2) TUNA, UNSPECIFIED 12 [hp_X] in 1 mL SALMON, UNSPECIFIED (UNII: 6122W2M0GB) (SALMON, UNSPECIFIED - UNII:6122W2M0GB) SALMON, UNSPECIFIED 12 [hp_X] in 1 mL LIMULUS POLYPHEMUS (UNII: 3R8874KEYH) (LIMULUS POLYPHEMUS - UNII:3R8874KEYH) LIMULUS POLYPHEMUS 12 [hp_X] in 1 mL OYSTER, UNSPECIFIED (UNII: S614XWR17V) (OYSTER, UNSPECIFIED - UNII:S614XWR17V) OYSTER, UNSPECIFIED 12 [hp_X] in 1 mL SHRIMP, UNSPECIFIED (UNII: 1891LE191T) (SHRIMP, UNSPECIFIED - UNII:1891LE191T) SHRIMP, UNSPECIFIED 12 [hp_X] in 1 mL CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 30 [hp_X] in 1 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 30 [hp_X] in 1 mL HYALURONIDASE (UNII: 8KOG53Z5EM) (HYALURONIDASE - UNII:8KOG53Z5EM) HYALURONIDASE 30 [hp_X] in 1 mL INTERFERON .GAMMA. PORCINE RECOMBINANT (UNII: 69404B0LO7) (INTERFERON .GAMMA. PORCINE RECOMBINANT - UNII:69404B0LO7) INTERFERON .GAMMA. PORCINE RECOMBINANT 30 [hp_X] in 1 mL SEROTONIN HYDROCHLORIDE (UNII: GKN429M9VS) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN HYDROCHLORIDE 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:43857-0241-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/26/2013 Labeler - BioActive Nutritional (624980496) Registrant - Apotheca Company (844330915) CloseEstablishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0241) , api manufacture(43857-0241) , label(43857-0241) , pack(43857-0241)
