Label: BOWEL SODE (ascaris lumbricoides, borrelia burgdorferi, colibacillinum cum natrum muriaticum, enterobius vermicularis, helicobacter pylori, proteus- vulgaris, trichinella spiralis, enterococcus faecalis, taenia saginatta, taenia solium, adenoviren nosode, campylobacter jejuni, clostridium perfringens, dysentery bacillus, giardia lamblia, clostridium difficile, entamoeba histolytica spray
- NDC Code(s): 83027-0147-1
- Packager: Nutritional Specialties, 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 November 12, 2024
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ACTIVE INGREDIENTS:
(in each spray) Adenoviren Nosode 12C, Ascaris Lumbricoides 16X, Borrelia Burgdorferi 16X, Campylobacter Jejuni 12C, Clostridium Difficile 32C, Clostridium Perfringens 18C, Colibacillinum Cum Natrum Muriaticum (E Coli) 16X, Dysentery Bacillus 18C, Entamoeba Histolytica 32C, Enterobius Vermicularis 16X, Enterococcus Faecalis 20X, Giardia Lamblia 18C, Helicobacter Pylori 16X, Proteus 16X, Taenia Saginatta 8C, Taenia Solium 8C, Trichinella Spiralis 16X
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PURPOSE:
Adenoviren Nosode – Aids in Temporary Relief of Fatigue,† Ascaris Lumbricoides – Aids in Temporary Relief of Irregular Bowel Habits, Diarrhea, Abdominal Pain, Bloating and Nausea,† Borrelia Burgdorferi – Aids in Temporary Relief of Abdominal Pain and Fatigue,† Campylobacter Jejuni – Aids in Temporary Relief of Diarrhea, Abdominal Pain and Nausea,† Clostridium Difficile – Aids in Temporary Relief of Diarrhea and Abdominal Pain,† Clostridium Perfringens – Aids in Temporary Relief of Diarrhea, Abdominal Pain, Bloating and Nausea,† Colibacillinum Cum Natrum Muriaticum (E Coli) – Aids in Temporary Relief of Diarrhea, Constipation, Abdominal Pain, Bloating and Nausea,† Dysentery Bacillus – Aids in Temporary Relief of Irregular Bowel Habits, Diarrhea, Constipation, Abdominal Pain, Bloating, Nausea and Fatigue,† Entamoeba Histolytica – Aids in Temporary Relief of Diarrhea, Abdominal Pain and Nausea,† Enterobius Vermicularis – Aids in Temporary Relief of Abdominal Pain, Itching of Anus and Fatigue,† Enterococcus Faecalis – Aids in Temporary Relief of Diarrhea, Abdominal Pain, Nausea and Fatigue,† Giardia Lamblia – Aids in Temporary Relief of Diarrhea, Abdominal Pain and Nausea,† Helicobacter Pylori – Aids in Temporary Relief of Abdominal Pain, Bloating, Nausea and Fatigue,† Proteus – Aids in Temporary Relief of Diarrhea, Constipation, Abdominal Pain, Itching of the Anus and Fatigue,† Taenia Saginatta – Aids in Temporary Relief of Diarrhea, Constipation, Abdominal Pain, Nausea and Fatigue,† Taenia Solium – Aids in Temporary Relief of Diarrhea, Constipation, Abdominal Pain and Nausea,† Trichinella Spiralis – Aids in Temporary Relief of Diarrhea, Constipation, Abdominal Pain, Nausea and Fatigue†
†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
- USES:
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WARNINGS:
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
If condition worsens, seek medical attention.
KEEP OUT OF REACH OF CHILDREN
Do not use if tamper evident seal is broken or missing.
Store in a cool place after opening
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
BOWEL SODE
ascaris lumbricoides, borrelia burgdorferi, colibacillinum cum natrum muriaticum, enterobius vermicularis, helicobacter pylori, proteus (vulgaris), trichinella spiralis, enterococcus faecalis, taenia saginatta, taenia solium, adenoviren nosode, campylobacter jejuni, clostridium perfringens, dysentery bacillus, giardia lamblia, clostridium difficile, entamoeba histolytica sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83027-0147 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCARIS LUMBRICOIDES (UNII: 5694HE17ZQ) (ASCARIS LUMBRICOIDES - UNII:5694HE17ZQ) ASCARIS LUMBRICOIDES 16 [hp_X] in 1 mL BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8) BORRELIA BURGDORFERI 16 [hp_X] in 1 mL ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI 16 [hp_X] in 1 mL ENTEROBIUS VERMICULARIS (UNII: W1D68QW48M) (ENTEROBIUS VERMICULARIS - UNII:W1D68QW48M) ENTEROBIUS VERMICULARIS 16 [hp_X] in 1 mL HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z) HELICOBACTER PYLORI 16 [hp_X] in 1 mL PROTEUS VULGARIS (UNII: 11T9HCO30O) (PROTEUS VULGARIS - UNII:11T9HCO30O) PROTEUS VULGARIS 16 [hp_X] in 1 mL TRICHINELLA SPIRALIS (UNII: 2PYI6D7HCQ) (TRICHINELLA SPIRALIS - UNII:2PYI6D7HCQ) TRICHINELLA SPIRALIS 16 [hp_X] in 1 mL ENTEROCOCCUS FAECALIS (UNII: 15E04LZ9CT) (ENTEROCOCCUS FAECALIS - UNII:15E04LZ9CT) ENTEROCOCCUS FAECALIS 20 [hp_X] in 1 mL TAENIA SAGINATA (UNII: O27XH54AIC) (TAENIA SAGINATA - UNII:O27XH54AIC) TAENIA SAGINATA 8 [hp_C] in 1 mL TAENIA SOLIUM (UNII: 80CZ5Z3WH3) (TAENIA SOLIUM - UNII:80CZ5Z3WH3) TAENIA SOLIUM 8 [hp_C] in 1 mL HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN (UNII: FKD3DUK39I) (HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 - UNII:FKD3DUK39I) HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN 12 [hp_C] in 1 mL CAMPYLOBACTER JEJUNI (UNII: 5U38E02853) (CAMPYLOBACTER JEJUNI - UNII:5U38E02853) CAMPYLOBACTER JEJUNI 12 [hp_C] in 1 mL CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E) (CLOSTRIDIUM PERFRINGENS - UNII:OVP6XX033E) CLOSTRIDIUM PERFRINGENS 18 [hp_C] in 1 mL SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (SHIGELLA DYSENTERIAE - UNII:1EP6R5562J) SHIGELLA DYSENTERIAE 18 [hp_C] in 1 mL GIARDIA LAMBLIA (UNII: 89IEJ09R73) (GIARDIA LAMBLIA - UNII:89IEJ09R73) GIARDIA LAMBLIA 18 [hp_C] in 1 mL CLOSTRIDIOIDES DIFFICILE (UNII: PJX89V9R6N) (CLOSTRIDIOIDES DIFFICILE - UNII:PJX89V9R6N) CLOSTRIDIOIDES DIFFICILE 32 [hp_C] in 1 mL ENTAMOEBA HISTOLYTICA (UNII: 2XC2HJ478W) (ENTAMOEBA HISTOLYTICA - UNII:2XC2HJ478W) ENTAMOEBA HISTOLYTICA 32 [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:83027-0147-1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/12/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/12/2024 Labeler - Nutritional Specialties, Inc. (032744609)