| NDC | 43742-1417-1 |
| Set ID | df5a3e16-9016-48ef-8118-ce15bf160de6 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Deseret Biologicals, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
-
ACTIVE INGREDIENTS:
Adenosinum Triphosphoricum Dinatrum 4X, Quercetin 6X, 8X, 10X, 30X, 200X, Rutin 6X, 8X, 10X, 30X, 200X, Ileum (Suis) 8X, Jejunum (Suis) 8X, Stomach (Suis) 8X, Bamboo 9X, 12X, 15X, 30X, Barley 9X, 12X, 15X, 30X, Poppy Seed 9X, 12X, 15X, 30X, Corn 9X, 12X, 15X, 30X, Flax Seed 9X, 12X, 15X, 30X, Cotton Seed 9X, 12X, 15X, 30X, Millet 9X, 12X, 15X, 30X, Milo 9X, 12X, 15X, 30X, Oat 9X, 12X, 15X, 30X, Rice 9X, 12X, 15X, 30X, Rye 9X, 12X, 15X, 30X, Safflower 9X, 12X, 15X, 30X, Sesame 9X, 12X, 15X, 30X, Sorghum 9X, 12X, 15X, 30X, Soy Bean 9X, 12X, 15X, 30X, Sugarcane 9X, 12X, 15X, 30X, Sunflower 9X, 12X, 15X, 30X, Wheat 9X, 12X, 15X, 30X, Bacillus Thuringiensis (BT Toxin) 10X, 30X, 200X, Gluten 30X, 200X, Amaranth 6C, 30C, 200C, Avena Sativa 6C, 30C, 200C, Natrum Sulphuricum 6C, 30C, 200C, Sarcolacticum Acidum 6C, 30C, 200C, Triticum Repens 6C, 30C, 200C, Adrenocorticotrophin 8C, 30C, 200C, Glyphosate 12C, 30C, 200C, 1M, Sycotic Co Bacillus 30C, 200C.
-
HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to consumption of grains, soy, and gluten, including bowel irregularity, occasional diarrhea, occasional constipation, and fatigue.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
-
HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to consumption of grains, soy, and gluten, including bowel irregularity, occasional diarrhea, occasional constipation, and fatigue.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INDICATIONS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
-
INGREDIENTS AND APPEARANCE
GRAIN AND SOY ALLERGEN MIX
adenosinum triphosphoricum dinatrum, quercetin, rutin, ileum (suis), jejunum (suis) stomach (suis), bamboo, barley, poppy seed, corn, flax seed, cotton seed, millet, milo, oat, rice, rye, safflower, sesame, sorghum, soy bean, sugarcane, sunflower, wheat, bacillus thuringiensis (bt toxin), gluten, amaranth, avena sativa, natrum sulphuricum, sarcolacticum acidum, triticum repens, adrenocorticotrophin, glyphosate, sycotic co bacillus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1417 Route of Administration ORAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE DISODIUM 4 [hp_X] in 1 mL QUERCETIN (UNII: 9IKM0I5T1E) (QUERCETIN - UNII:9IKM0I5T1E) QUERCETIN 6 [hp_X] in 1 mL RUTIN (UNII: 5G06TVY3R7) (RUTIN - UNII:5G06TVY3R7) RUTIN 6 [hp_X] in 1 mL SUS SCROFA ILEUM (UNII: C998R1XSRA) (SUS SCROFA ILEUM - UNII:C998R1XSRA) SUS SCROFA ILEUM 8 [hp_X] in 1 mL SUS SCROFA JEJUNUM (UNII: TA501QD69R) (SUS SCROFA JEJUNUM - UNII:TA501QD69R) SUS SCROFA JEJUNUM 8 [hp_X] in 1 mL SUS SCROFA STOMACH (UNII: T0920P9Z9A) (SUS SCROFA STOMACH - UNII:T0920P9Z9A) SUS SCROFA STOMACH 8 [hp_X] in 1 mL BAMBUSA VULGARIS LEAF (UNII: EMY54R518C) (BAMBUSA VULGARIS LEAF - UNII:EMY54R518C) BAMBUSA VULGARIS LEAF 9 [hp_X] in 1 mL BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY 9 [hp_X] in 1 mL POPPY SEED (UNII: 60RO23IR87) (POPPY SEED - UNII:60RO23IR87) POPPY SEED 9 [hp_X] in 1 mL CORN (UNII: 0N8672707O) (CORN - UNII:0N8672707O) CORN 9 [hp_X] in 1 mL FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C) FLAX SEED 9 [hp_X] in 1 mL LEVANT COTTON SEED (UNII: 550E4N439V) (LEVANT COTTON SEED - UNII:550E4N439V) LEVANT COTTON SEED 9 [hp_X] in 1 mL MILLET (UNII: TJR6B3R47P) (MILLET - UNII:TJR6B3R47P) MILLET 9 [hp_X] in 1 mL SORGHUM BICOLOR WHOLE (UNII: Y3T98X3AL6) (SORGHUM BICOLOR WHOLE - UNII:Y3T98X3AL6) SORGHUM BICOLOR WHOLE 9 [hp_X] in 1 mL OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT 9 [hp_X] in 1 mL BROWN RICE (UNII: 659G217HPG) (BROWN RICE - UNII:659G217HPG) BROWN RICE 9 [hp_X] in 1 mL RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X) RYE 9 [hp_X] in 1 mL SAFFLOWER (UNII: 4VBL71TY4Y) (SAFFLOWER - UNII:4VBL71TY4Y) SAFFLOWER 9 [hp_X] in 1 mL SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR) SESAME SEED 9 [hp_X] in 1 mL SORGHUM (UNII: CUL9PN8ELJ) (SORGHUM - UNII:CUL9PN8ELJ) SORGHUM 9 [hp_X] in 1 mL SOYBEAN (UNII: L7HT8F1ZOD) (SOYBEAN - UNII:L7HT8F1ZOD) SOYBEAN 9 [hp_X] in 1 mL SUGARCANE (UNII: 81H2R5AOH3) (SUGARCANE - UNII:81H2R5AOH3) SUGARCANE 9 [hp_X] in 1 mL SUNFLOWER SEED (UNII: R9N3379M4Z) (SUNFLOWER SEED - UNII:R9N3379M4Z) SUNFLOWER SEED 9 [hp_X] in 1 mL WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT 9 [hp_X] in 1 mL BACILLUS THURINGIENSIS (UNII: 3TK3LQP1N7) (BACILLUS THURINGIENSIS - UNII:3TK3LQP1N7) BACILLUS THURINGIENSIS 10 [hp_X] in 1 mL WHEAT GLUTEN (UNII: 1534K8653J) (WHEAT GLUTEN - UNII:1534K8653J) WHEAT GLUTEN 30 [hp_X] in 1 mL AMARANTH (UNII: 37RBV3X49K) (AMARANTH ACID - UNII:02J7X17ZUQ) AMARANTH 6 [hp_C] in 1 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 6 [hp_C] in 1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 6 [hp_C] in 1 mL LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 6 [hp_C] in 1 mL ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W) (ELYMUS REPENS ROOT - UNII:3IXW0F6P8W) ELYMUS REPENS ROOT 6 [hp_C] in 1 mL CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN 8 [hp_C] in 1 mL GLYPHOSATE (UNII: 4632WW1X5A) (GLYPHOSATE - UNII:4632WW1X5A) GLYPHOSATE 12 [hp_C] in 1 mL ENTEROCOCCUS FAECALIS (UNII: 15E04LZ9CT) (ENTEROCOCCUS FAECALIS - UNII:15E04LZ9CT) ENTEROCOCCUS FAECALIS 30 [hp_C] 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:43742-1417-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/02/2019 02/25/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/02/2019 02/25/2025 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1417) , api manufacture(43742-1417) , label(43742-1417) , pack(43742-1417)
