Label: GRAIN AND SOY ALLERGEN MIX (adenosinum triphosphoricum dinatrum, quercetin, rutin, natrum carbonicum, ileum (suis), jejunum (suis) stomach- suis, gluten, amaranth, avena sativa, natrum sulphuricum, sarcolacticum acidum, triticum repens, cortisone aceticum, glyphosate, sycotic co bacillus liquid
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- NDC Code(s): 43742-1627-1
- Packager: Deseret Biologicals, 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 July 11, 2022
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ACTIVE INGREDIENTS:
Adenosinum Triphosphoricum Dinatrum 4X, Quercetin 6X, 8X, 10X, 30X, 200X, Rutin 6X, 8X, 10X, 30X, 200X, Natrum Carbonicum 6X, 12X, 30X, Ileum (Suis) 8X, Jejunum (Suis) 8X, Stomach (Suis) 8X, 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, Cortisone Aceticum 8C, 30C, 200C, Glyphosate 12C, 30C, 200C, 1000C, Sycotic Co Bacillus 30C, 200C.
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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 homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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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 homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INDICATIONS:
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INGREDIENTS AND APPEARANCE
GRAIN AND SOY ALLERGEN MIX
adenosinum triphosphoricum dinatrum, quercetin, rutin, natrum carbonicum, ileum (suis), jejunum (suis) stomach (suis), gluten, amaranth, avena sativa, natrum sulphuricum, sarcolacticum acidum, triticum repens, cortisone aceticum, glyphosate, sycotic co bacillus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1627 Route of Administration ORAL 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 SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 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 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 CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 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:43742-1627-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2020 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1627) , api manufacture(43742-1627) , label(43742-1627) , pack(43742-1627)
