Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID caf62710-f8f0-4ca5-b3ac-6bc79af044a5
Route
ORAL
Published
Effective Date 2023-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ascaris Lumbricoides (16 [hp_X]) Borrelia Burgdorferi (20 [hp_X]) Clostridium Botulinum (8 [hp_C]) Escherichia Coli (12 [hp_C]) Enterobius Vermicularis (18 [hp_C]) Giardia Lamblia (32 [hp_C]) Helicobacter Pylori Proteus Vulgaris Trichinella Spiralis Enterococcus Faecalis Taenia Saginata Taenia Solium Human Adenovirus E Serotype 4 Strain Cl-68578 Campylobacter Jejuni Clostridium Perfringens Shigella Dysenteriae Clostridium Difficile Entamoeba Histolytica
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2023-09-15 Until 2028-09-20

Description

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.


Medication Information

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.

Description

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

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

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.

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.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0072-1

BOWEL-SODE

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (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: (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

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions: (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: (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.

Active Ingredients: (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.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0072-1

BOWEL-SODE

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

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


Advanced Ingredient Data


Raw Label Data

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