Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID acb43b1a-52fd-484b-96a8-1cfe97c1f398
Route
ORAL
Published
Effective Date 2023-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Artemisia Vulgaris Root (3 [hp_X]) Artemisia Cina Flower (4 [hp_X]) Schoenocaulon Officinale Seed (12 [hp_X]) Spigelia Anthelmia (30 [hp_X]) Dryopteris Filix-mas Root Barium Cation Oyster Shell Calcium Carbonate, Crude Cinchona Officinalis Bark Phosphate Ion Sulfur Turpentine Oil Proteus Vulgaris
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-11-02

Description

(in each drop) Baryta Carbonica 12X 12.45%, Calcarea Carbonica 12X 12.45%, Cinchona Officinalis 12X 12.45%, Filix Mas 4X 12.45%, Natrum Phosphoricum 12X 12.45%, Proteus 30X 12.45%, Sulphur 12X 12.45%, Terebinthina 12X 12.45%, Artemisia Vulgaris 3X 0.10%, Cina 3X 0.10%, Sabadilla 3X 0.10%, Spigelia Anthelmia 3X 0.10%.

Purpose

Baryta Carbonica – painful stools,** Calcarea Carbonica - constipation,** Cinchona Officinalis - bloating,** Filix Mas - colic,** Natrum Phosphoricum – increased appetite,** Proteus - anger,** Sulphur - burning,** Terebinthina - irritability,** Artemisia Vulgaris - diarrhea,** Cina - moodiness,** Sabadilla - itching,** Spigelia Anthelmia - nausea.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Baryta Carbonica – painful stools,** Calcarea Carbonica - constipation,** Cinchona Officinalis - bloating,** Filix Mas - colic,** Natrum Phosphoricum – increased appetite,** Proteus - anger,** Sulphur - burning,** Terebinthina - irritability,** Artemisia Vulgaris - diarrhea,** Cina - moodiness,** Sabadilla - itching,** Spigelia Anthelmia - nausea.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop) Baryta Carbonica 12X 12.45%, Calcarea Carbonica 12X 12.45%, Cinchona Officinalis 12X 12.45%, Filix Mas 4X 12.45%, Natrum Phosphoricum 12X 12.45%, Proteus 30X 12.45%, Sulphur 12X 12.45%, Terebinthina 12X 12.45%, Artemisia Vulgaris 3X 0.10%, Cina 3X 0.10%, Sabadilla 3X 0.10%, Spigelia Anthelmia 3X 0.10%.

Uses:

May temporarily relieve: • itching of anus • colic • bloating • pain • constipation**

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

Purpose:

Baryta Carbonica – painful stools,** Calcarea Carbonica - constipation,** Cinchona Officinalis - bloating,** Filix Mas - colic,** Natrum Phosphoricum – increased appetite,** Proteus - anger,** Sulphur - burning,** Terebinthina - irritability,** Artemisia Vulgaris - diarrhea,** Cina - moodiness,** Sabadilla - itching,** Spigelia Anthelmia - nausea.**

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

Warnings:

Stop use and ask a doctor if symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a health professional before use.

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

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING

Store in a cool, dry place.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800.869.8078

Directions:

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.

• Consult a physician for use in children under 12 years of age.

Active Ingredients:

(in each drop) Baryta Carbonica 12X 12.45%, Calcarea Carbonica 12X 12.45%, Cinchona Officinalis 12X 12.45%, Filix Mas 4X 12.45%, Natrum Phosphoricum 12X 12.45%, Proteus 30X 12.45%, Sulphur 12X 12.45%, Terebinthina 12X 12.45%, Artemisia Vulgaris 3X 0.10%, Cina 3X 0.10%, Sabadilla 3X 0.10%, Spigelia Anthelmia 3X 0.10%.

Inactive Ingredients:

Demineralized water, 20% ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

VERMISTAT

1 fl. oz. (30 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:)

May temporarily relieve: • itching of anus • colic • bloating • pain • constipation**

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

Purpose: (PURPOSE:)

Baryta Carbonica – painful stools,** Calcarea Carbonica - constipation,** Cinchona Officinalis - bloating,** Filix Mas - colic,** Natrum Phosphoricum – increased appetite,** Proteus - anger,** Sulphur - burning,** Terebinthina - irritability,** Artemisia Vulgaris - diarrhea,** Cina - moodiness,** Sabadilla - itching,** Spigelia Anthelmia - nausea.**

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

Warnings: (WARNINGS:)

Stop use and ask a doctor if symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a health professional before use.

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

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING

Store in a cool, dry place.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800.869.8078

Directions: (DIRECTIONS:)

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.

• Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) Baryta Carbonica 12X 12.45%, Calcarea Carbonica 12X 12.45%, Cinchona Officinalis 12X 12.45%, Filix Mas 4X 12.45%, Natrum Phosphoricum 12X 12.45%, Proteus 30X 12.45%, Sulphur 12X 12.45%, Terebinthina 12X 12.45%, Artemisia Vulgaris 3X 0.10%, Cina 3X 0.10%, Sabadilla 3X 0.10%, Spigelia Anthelmia 3X 0.10%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

VERMISTAT

1 fl. oz. (30 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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