Label: LEAKY GUT FORMULA (alfalfa, glycyrrhiza glabra, aloe, astacus fluviatilis, berberis aquifolium, lac defloratum, natrum carbonicum, saccharum officinale, fel tauri, pancreas suis, pancreatinum, fragaria vesca, antimonium crudum, carbo vegetabilis, euphorbium officinarum, lycopodium clavatum, magnesia carbonica, zincum metallicum, colibacillinum cum natrum muriaticum, proteus- vulgaris liquid
- NDC Code(s): 43742-1535-1
- Packager: Deseret Biologicals, Inc.
- 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 January 20, 2021
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ACTIVE INGREDIENTS:
Alfalfa 3X, Glycyrrhiza Glabra 3X, Aloe 4X, Astacus Fluviatilis 6X, Berberis Aquifolium 6X, Lac Defloratum 6X, Natrum Carbonicum 6X, Saccharum Officinale 6X, Fel Tauri 8X, Pancreas Suis 8X, Pancreatinum 8X, Fragaria Vesca 9X, Antimonium Crudum 12X, Carbo Vegetabilis 12X, Euphorbium Officinarum 12X, Lycopodium Clavatum 12X, Magnesia Carbonica 12X, Zincum Metallicum 12X, Colibacillinum 15X, 30X, 60X, 100X, 200X, Proteus (Vulgaris) 15X, 30X, 60X, 100X, 200X.
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HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to leaky gut syndrome such as fatigue, seasonal allergies, joint pain, occasional constipation, mental fogginess and occasional diarrhea.**
**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:
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HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to leaky gut syndrome such as fatigue, seasonal allergies, joint pain, occasional constipation, mental fogginess and occasional diarrhea.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
LEAKY GUT FORMULA
alfalfa, glycyrrhiza glabra, aloe, astacus fluviatilis, berberis aquifolium, lac defloratum, natrum carbonicum, saccharum officinale, fel tauri, pancreas suis, pancreatinum, fragaria vesca, antimonium crudum, carbo vegetabilis, euphorbium officinarum, lycopodium clavatum, magnesia carbonica, zincum metallicum, colibacillinum cum natrum muriaticum, proteus (vulgaris) liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1535 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA 3 [hp_X] in 1 mL GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA 3 [hp_X] in 1 mL ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE 4 [hp_X] in 1 mL ASTACUS ASTACUS (UNII: V0551986XQ) (ASTACUS ASTACUS - UNII:V0551986XQ) ASTACUS ASTACUS 6 [hp_X] in 1 mL BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB) BERBERIS AQUIFOLIUM ROOT BARK 6 [hp_X] in 1 mL SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK 6 [hp_X] in 1 mL SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 6 [hp_X] in 1 mL SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE 6 [hp_X] in 1 mL BOS TAURUS BILE (UNII: ET3651ZLOU) (BOS TAURUS BILE - UNII:ET3651ZLOU) BOS TAURUS BILE 8 [hp_X] in 1 mL SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS 8 [hp_X] in 1 mL PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE 8 [hp_X] in 1 mL ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY 9 [hp_X] in 1 mL ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE 12 [hp_X] in 1 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 12 [hp_X] in 1 mL EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN 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 MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE 12 [hp_X] in 1 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 12 [hp_X] in 1 mL ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI 15 [hp_X] in 1 mL PROTEUS VULGARIS (UNII: 11T9HCO30O) (PROTEUS VULGARIS - UNII:11T9HCO30O) PROTEUS VULGARIS 15 [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:43742-1535-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/22/2019 05/05/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/22/2019 05/05/2025 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1535) , api manufacture(43742-1535) , label(43742-1535) , pack(43742-1535)
