Bowel Sode: Homeopathic Product Information

BOWEL SODE- ascaris lumbricoides, borrelia burgdorferi, clostridium botulinum, escherichia coli, enterobius vermicularis, giardia lamblia, helicobacter pylori, proteus vulgaris, trichinella spiralis, enterococcus faecalis, taenia saginata, taenia solium, human adenovirus e serotype 4 strain cl-68578 antigen, campylobacter jejuni, clostridium perfringens, shigella dysenteriae, clostridium difficile and entamoeba histolytica spray
Nutritional Specialties, Inc.

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.

ACTIVE INGREDIENTS:

Ascaris Lumbricoides 16X, Borrelia Burgdorferi 16X, Botulinum 16X, Colibacillinum Cum Natrum Muriaticum 16X, Enterobius Vermicularis 16X, Giardia Lamblia 16X, Helicobacter Pylori 16X, Proteus (Vulgaris) 16X, Trichinella Spiralis 16X, Enterococcus Faecalis 20X, Taenia Saginatta 8C, Taenia Solium 8C, Adenoviren Nosode 12C, Campylobacter Jejuni 12C, Clostridium Perfringens 18C, Dysentery Bacillus 18C, Clostridium Difficile 32C, Entamoeba Histolytica 32C.

PURPOSE:

Aids in temporary relief of symptoms including irregular bowel habits, diarrhea, constipation, abdominal pain, bloating, nausea, itching of the anus and fatigue.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

Professional Use Only

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:

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

INDICATIONS:

Aids in temporary relief of symptoms including irregular bowel habits, diarrhea, constipation, abdominal pain, bloating, nausea, itching of the anus and fatigue.†
†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0072-1

BOWEL-SODE

2 FL. OZ (60 ml)

BOWEL SODE ascaris lumbricoides, borrelia burgdorferi, botulinum, colibacillinum cum natrum muriaticum, enterobius vermicularis, giardia lamblia, helicobacter pylori, proteus (vulgaris), trichinella spiralis, enterococcus faecalis, taenia saginatta, taenia solium, adenoviren nosode, campylobacter jejuni, clostridium perfringens, dysentery bacillus, clostridium difficile, entamoeba histolytica spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83027-0072 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCARIS LUMBRICOIDES (ASCARIS LUMBRICOIDES) ASCARIS LUMBRICOIDES 16 [hp_X] in 1 mL BORRELIA BURGDORFERI (BORRELIA BURGDORFERI) BORRELIA BURGDORFERI 16 [hp_X] in 1 mL CLOSTRIDIUM BOTULINUM (CLOSTRIDIUM BOTULINUM) CLOSTRIDIUM BOTULINUM 16 [hp_X] in 1 mL ESCHERICHIA COLI (ESCHERICHIA COLI) ESCHERICHIA COLI 16 [hp_X] in 1 mL ENTEROBIUS VERMICULARIS (ENTEROBIUS VERMICULARIS) ENTEROBIUS VERMICULARIS 16 [hp_X] in 1 mL GIARDIA LAMBLIA (GIARDIA LAMBLIA) GIARDIA LAMBLIA 16 [hp_X] in 1 mL HELICOBACTER PYLORI (HELICOBACTER PYLORI) HELICOBACTER PYLORI 16 [hp_X] in 1 mL PROTEUS VULGARIS (PROTEUS VULGARIS) PROTEUS VULGARIS 16 [hp_X] in 1 mL TRICHINELLA SPIRALIS (TRICHINELLA SPIRALIS) TRICHINELLA SPIRALIS 16 [hp_X] in 1 mL ENTEROCOCCUS FAECALIS (ENTEROCOCCUS FAECALIS) ENTEROCOCCUS FAECALIS 20 [hp_X] in 1 mL TAENIA SAGINATA (TAENIA SAGINATA) TAENIA SAGINATA 8 [hp_C] in 1 mL TAENIA SOLIUM (TAENIA SOLIUM) TAENIA SOLIUM 8 [hp_C] in 1 mL HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN (HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578) HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN 12 [hp_C] in 1 mL CAMPYLOBACTER JEJUNI (CAMPYLOBACTER JEJUNI) CAMPYLOBACTER JEJUNI 12 [hp_C] in 1 mL CLOSTRIDIUM PERFRINGENS (CLOSTRIDIUM PERFRINGENS) CLOSTRIDIUM PERFRINGENS 18 [hp_C] in 1 mL SHIGELLA DYSENTERIAE (SHIGELLA DYSENTERIAE) SHIGELLA DYSENTERIAE 18 [hp_C] in 1 mL CLOSTRIDIUM DIFFICILE (CLOSTRIDIUM DIFFICILE) CLOSTRIDIUM DIFFICILE 32 [hp_C] in 1 mL ENTAMOEBA HISTOLYTICA (ENTAMOEBA HISTOLYTICA) ENTAMOEBA HISTOLYTICA 32 [hp_C] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:83027-0072-1 60 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/15/2023

Labeler — Nutritional Specialties, Inc. (032744609)

Revised: 09/2023 Nutritional Specialties, Inc.