Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 91f2500c-411f-4ef9-81f7-76e93d9bb3a5
Route
ORAL
Published
Effective Date 2023-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (30 [hp_X]) Milk Thistle Chelidonium Majus Chionanthus Virginicus Root Bark Cinchona Officinalis Bark Citrullus Colocynthis Fruit Pulp Veronicastrum Virginicum Root Lycopodium Clavatum Spore Sodium Sulfate Anhydrous Strychnos Nux-vomica Seed Phosphorus Ptelea Trifoliata Bark Pulsatilla Pratensis Whole Veratrum Album Root
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-08-04

Description

(in each drop) Belladonna 30X 7.14%, Carduus Marianus 30X 7.14%, Chelidonium Majus 30X 7.14%, Chionanthus Virginica 30X 7.14%, Cinchona Officinalis 30X 7.14%, Colocynthis 30X 7.14%, Leptandra Virginica 30X 7.14%, Lycopodium Clavatum 30X 7.14%, Natrum Sulphuricum 30X 7.14%, Nux Vomica 30X 7.14%, Phosphorus 30X 7.14%, Ptelea Trifoliata 30X 7.14%, Pulsatilla 30X 7.14%, Veratrum Album 30X 7.14%.

Purpose

Belladonna – colic,** Carduus Marianus - headache,** Chelidonium Majus – right shoulder pain,** Chionanthus Virginica - constipation, Cinchona Officinalis - bloating,** Colocynthis - flatulence,** Leptandra Virginica - fever,** Lycopodium Clavatum – easy satiety, Natrum Sulphuricum – bitter taste,** Nux Vomica - nausea,** Phosphorus - fatigue,** Ptelea Trifoliata – abdominal discomfort,** Pulsatilla - indigestion,** Veratrum Album - diarrhea.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Belladonna – colic,** Carduus Marianus - headache,** Chelidonium Majus – right shoulder pain,** Chionanthus Virginica - constipation, Cinchona Officinalis - bloating,** Colocynthis - flatulence,** Leptandra Virginica - fever,** Lycopodium Clavatum – easy satiety, Natrum Sulphuricum – bitter taste,** Nux Vomica - nausea,** Phosphorus - fatigue,** Ptelea Trifoliata – abdominal discomfort,** Pulsatilla - indigestion,** Veratrum Album - diarrhea.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop) Belladonna 30X 7.14%, Carduus Marianus 30X 7.14%, Chelidonium Majus 30X 7.14%, Chionanthus Virginica 30X 7.14%, Cinchona Officinalis 30X 7.14%, Colocynthis 30X 7.14%, Leptandra Virginica 30X 7.14%, Lycopodium Clavatum 30X 7.14%, Natrum Sulphuricum 30X 7.14%, Nux Vomica 30X 7.14%, Phosphorus 30X 7.14%, Ptelea Trifoliata 30X 7.14%, Pulsatilla 30X 7.14%, Veratrum Album 30X 7.14%.

Uses:

May temporarily relieve: •flatulence •constipation •belching •abdominal discomfort

•hemorrhoids •indigestion after eating (especially fat)**

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

Purposes:

Belladonna – colic,** Carduus Marianus - headache,** Chelidonium Majus – right shoulder pain,** Chionanthus Virginica - constipation, Cinchona Officinalis - bloating,** Colocynthis - flatulence,** Leptandra Virginica - fever,** Lycopodium Clavatum – easy satiety, Natrum Sulphuricum – bitter taste,** Nux Vomica - nausea,** Phosphorus - fatigue,** Ptelea Trifoliata – abdominal discomfort,** Pulsatilla - indigestion,** Veratrum Album - diarrhea.**

**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) Belladonna 30X 7.14%, Carduus Marianus 30X 7.14%, Chelidonium Majus 30X 7.14%, Chionanthus Virginica 30X 7.14%, Cinchona Officinalis 30X 7.14%, Colocynthis 30X 7.14%, Leptandra Virginica 30X 7.14%, Lycopodium Clavatum 30X 7.14%, Natrum Sulphuricum 30X 7.14%, Nux Vomica 30X 7.14%, Phosphorus 30X 7.14%, Ptelea Trifoliata 30X 7.14%, Pulsatilla 30X 7.14%, Veratrum Album 30X 7.14%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

LIVER

GALLBLADDER HP

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: •flatulence •constipation •belching •abdominal discomfort

•hemorrhoids •indigestion after eating (especially fat)**

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

Purposes: (PURPOSES:)

Belladonna – colic,** Carduus Marianus - headache,** Chelidonium Majus – right shoulder pain,** Chionanthus Virginica - constipation, Cinchona Officinalis - bloating,** Colocynthis - flatulence,** Leptandra Virginica - fever,** Lycopodium Clavatum – easy satiety, Natrum Sulphuricum – bitter taste,** Nux Vomica - nausea,** Phosphorus - fatigue,** Ptelea Trifoliata – abdominal discomfort,** Pulsatilla - indigestion,** Veratrum Album - diarrhea.**

**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) Belladonna 30X 7.14%, Carduus Marianus 30X 7.14%, Chelidonium Majus 30X 7.14%, Chionanthus Virginica 30X 7.14%, Cinchona Officinalis 30X 7.14%, Colocynthis 30X 7.14%, Leptandra Virginica 30X 7.14%, Lycopodium Clavatum 30X 7.14%, Natrum Sulphuricum 30X 7.14%, Nux Vomica 30X 7.14%, Phosphorus 30X 7.14%, Ptelea Trifoliata 30X 7.14%, Pulsatilla 30X 7.14%, Veratrum Album 30X 7.14%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

LIVER

GALLBLADDER HP

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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