Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 9af75f01-ef40-4166-a02f-e08d49f3003e
Route
ORAL
Published
Effective Date 2023-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Purpurea (3 [hp_X]) Glycyrrhiza Glabra (6 [hp_X]) Goldenseal (8 [hp_X]) Podophyllum (18 [hp_X]) Aconitum Napellus (30 [hp_X]) Citrullus Colocynthis Fruit Pulp (8 [hp_C]) Arsenic Cation (3+) (18 [hp_C]) Escherichia Coli Salmonella Enterica Enterica Serovar Typhi Staphylococcus Aureus Streptococcus Viridans Group Mercuric Cation Mercurius Solubilis Aconitum Lycoctonum Whole Campylobacter Jejuni Clostridium Perfringens Listeria Monocytogenes
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-11-01

Description

Echinacea Purpurea 3X, Glycyrrhiza Glabra 3X, Hydrastis Canadensis 6X, Podophyllum Peltatum 6X, Aconitum Napellus 8X, 12X, Colocynthis 8X, 12X, Arsenicum Album 8X, 12X, 30X, Colibacillinum Cum Natrum Muriaticum (Escherichia Coli) 18X, 30X, Salmonella Typhi Nosode 18X, 30X, Staphylococcus Aureus 18X, 30X, Streptococcus Viridans 18X, 30X, Mercurius Corrosivus 30X, Mercurius Solubilis 30X, Aconitum Lycoctonum 8C, 12C, Campylobacter Jejuni 18C, 30C, Clostridium Perfringens 18C, 30C, Listeria Monocytogenes 18C, 30C.

Purpose

Aids in temporary relief of symptoms of food poisoning such as nausea, diarrhea, cramping, bloating, and feelings of gastrointestinal† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in temporary relief of symptoms of food poisoning such as nausea, diarrhea, cramping, bloating, and feelings of gastrointestinal† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Echinacea Purpurea 3X, Glycyrrhiza Glabra 3X, Hydrastis Canadensis 6X, Podophyllum Peltatum 6X, Aconitum Napellus 8X, 12X, Colocynthis 8X, 12X, Arsenicum Album 8X, 12X, 30X, Colibacillinum Cum Natrum Muriaticum (Escherichia Coli) 18X, 30X, Salmonella Typhi Nosode 18X, 30X, Staphylococcus Aureus 18X, 30X, Streptococcus Viridans 18X, 30X, Mercurius Corrosivus 30X, Mercurius Solubilis 30X, Aconitum Lycoctonum 8C, 12C, Campylobacter Jejuni 18C, 30C, Clostridium Perfringens 18C, 30C, Listeria Monocytogenes 18C, 30C.

Purpose:

Aids in temporary relief of symptoms of food poisoning such as nausea, diarrhea, cramping, bloating, and feelings of gastrointestinal†

†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 of food poisoning such as nausea, diarrhea, cramping, bloating, and feelings of gastrointestinal†

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

Active Ingredients:

Echinacea Purpurea 3X, Glycyrrhiza Glabra 3X, Hydrastis Canadensis 6X, Podophyllum Peltatum 6X, Aconitum Napellus 8X, 12X, Colocynthis 8X, 12X, Arsenicum Album 8X, 12X, 30X, Colibacillinum Cum Natrum Muriaticum (Escherichia Coli) 18X, 30X, Salmonella Typhi Nosode 18X, 30X, Staphylococcus Aureus 18X, 30X, Streptococcus Viridans 18X, 30X, Mercurius Corrosivus 30X, Mercurius Solubilis 30X, Aconitum Lycoctonum 8C, 12C, Campylobacter Jejuni 18C, 30C, Clostridium Perfringens 18C, 30C, Listeria Monocytogenes 18C, 30C.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0121-1

FOOD POISONING

DETOX

2 FL. OZ (60 ml)

F

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 of food poisoning such as nausea, diarrhea, cramping, bloating, and feelings of gastrointestinal†

†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 of food poisoning such as nausea, diarrhea, cramping, bloating, and feelings of gastrointestinal†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea Purpurea 3X, Glycyrrhiza Glabra 3X, Hydrastis Canadensis 6X, Podophyllum Peltatum 6X, Aconitum Napellus 8X, 12X, Colocynthis 8X, 12X, Arsenicum Album 8X, 12X, 30X, Colibacillinum Cum Natrum Muriaticum (Escherichia Coli) 18X, 30X, Salmonella Typhi Nosode 18X, 30X, Staphylococcus Aureus 18X, 30X, Streptococcus Viridans 18X, 30X, Mercurius Corrosivus 30X, Mercurius Solubilis 30X, Aconitum Lycoctonum 8C, 12C, Campylobacter Jejuni 18C, 30C, Clostridium Perfringens 18C, 30C, Listeria Monocytogenes 18C, 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0121-1

FOOD POISONING

DETOX

2 FL. OZ (60 ml)

F

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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