Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 9390968d-6316-4f3f-a041-831275fd4135
Route
ORAL
Published
Effective Date 2023-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cinchona Officinalis Bark (3 [hp_X]) Rheum Palmatum Root (4 [hp_X]) Podophyllum (5 [hp_X]) Ipecac (6 [hp_X]) Aloe (7 [hp_X]) Citrullus Colocynthis Fruit Pulp (8 [hp_X]) Arsenic Cation (3+) (9 [hp_X]) Turpentine Oil (12 [hp_X]) Veratrum Album Root Antimony Trisulfide Mercuric Cation
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-10-05

Description

Cinchona Officinalis 3X, 6X, Rheum 4X, Podophyllum Peltatum 5X, 6X, Ipecacuanha 6X, Aloe 6X, 12X, Colocynthis 7X, Arsenicum Album 8X, Terebinthina 8X, Veratrum Album 8X, 12X, Antimonium Crudum9X, Mercurius Corrosivus 12X.

Purpose

Aids in temporary relief of loose & watery stools.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in temporary relief of loose & watery stools.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Cinchona Officinalis 3X, 6X, Rheum 4X, Podophyllum Peltatum 5X, 6X, Ipecacuanha 6X, Aloe 6X, 12X, Colocynthis 7X, Arsenicum Album 8X, Terebinthina 8X, Veratrum Album 8X, 12X, Antimonium Crudum9X, Mercurius Corrosivus 12X.

Purpose:

Aids in temporary relief of loose & watery stools.†

†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 loose & watery stools.†

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

Active Ingredients:

Cinchona Officinalis 3X, 6X, Rheum 4X, Podophyllum Peltatum 5X, 6X, Ipecacuanha 6X, Aloe 6X, 12X, Colocynthis 7X, Arsenicum Album 8X, Terebinthina 8X, Veratrum Album 8X, 12X, Antimonium Crudum9X, Mercurius Corrosivus 12X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Keep Out of Reach of Children:

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

Package Label.principal Display Panel

Professional

Health Products

HOMEOPATHIC

NDC 83027-0110-1

DIARRHEA 

FORMULA

2 FL. OZ (60 ml)


Structured Label Content

Purpose: (PURPOSE:)

Aids in temporary relief of loose & watery stools.†

†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 loose & watery stools.†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Cinchona Officinalis 3X, 6X, Rheum 4X, Podophyllum Peltatum 5X, 6X, Ipecacuanha 6X, Aloe 6X, 12X, Colocynthis 7X, Arsenicum Album 8X, Terebinthina 8X, Veratrum Album 8X, 12X, Antimonium Crudum9X, Mercurius Corrosivus 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0110-1

DIARRHEA 

FORMULA

2 FL. OZ (60 ml)


Advanced Ingredient Data


Raw Label Data

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