Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID cf584823-7b5d-4b72-8c37-5213a756fabd
Route
ORAL
Published
Effective Date 2023-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Black Walnut Husk (2 [hp_X]) Berberis Vulgaris Root Bark (3 [hp_X]) Artemisia Abrotanum Flowering Top (4 [hp_X]) Schoenocaulon Officinale Seed (7 [hp_X]) Spigelia Anthelmia (12 [hp_X]) Teucrium Marum (16 [hp_X]) Dryopteris Filix-mas Root Copper Chelone Glabra
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-07-24

Description

Juglans Nigra 2X, Berberis Vulgaris 3X, Abrotanum 4X, Sabadilla 4X, Spigelia Anthelmia 4X, Teucrium Marum 4X, Filix Mas 7X, Cuprum Metallicum 12X, Chelone Glabra 16X.

Purpose

Aids in temporary relief of symptoms including constipation, colic, bloating, and itching of the anus.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in temporary relief of symptoms including constipation, colic, bloating, and itching of the anus.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Juglans Nigra 2X, Berberis Vulgaris 3X, Abrotanum 4X, Sabadilla 4X, Spigelia Anthelmia 4X, Teucrium Marum 4X, Filix Mas 7X, Cuprum Metallicum 12X, Chelone Glabra 16X.

Purpose:

Aids in temporary relief of symptoms including constipation, colic, bloating, and itching of the anus.†

†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.

For highly sensitive individuals: best tolerated administration is through imbrication (RUBBING IN) on skin at pulse points or abdomen.

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 constipation, colic, bloating, and itching of the anus.†

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

Active Ingredients:

Juglans Nigra 2X, Berberis Vulgaris 3X, Abrotanum 4X, Sabadilla 4X, Spigelia Anthelmia 4X, Teucrium Marum 4X, Filix Mas 7X, Cuprum Metallicum 12X, Chelone Glabra 16X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0049-1

VERMEX

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 constipation, colic, bloating, and itching of the anus.†

†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.

For highly sensitive individuals: best tolerated administration is through imbrication (RUBBING IN) on skin at pulse points or abdomen.

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 constipation, colic, bloating, and itching of the anus.†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Juglans Nigra 2X, Berberis Vulgaris 3X, Abrotanum 4X, Sabadilla 4X, Spigelia Anthelmia 4X, Teucrium Marum 4X, Filix Mas 7X, Cuprum Metallicum 12X, Chelone Glabra 16X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0049-1

VERMEX

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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