Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2199e2ff-8ce7-430a-9adb-5bccacd8b9db
Route
ORAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-11-12

Description

(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

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.


Medication Information

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.

Description

(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

Uses:

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.

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.

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

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

1-800-245-1313

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.

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

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0147-1

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

Uses: (USES:)

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.

Purpose: (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.

Warnings: (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

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

1-800-245-1313

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.

Active Ingredients: (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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0147-1

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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