Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID f5fb248f-e078-4dba-9bee-be0e803b6a13
Route
ORAL
Published
Effective Date 2021-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clematis Vitalba Flower (3 [hp_X]) Helianthemum Nummularium Flower (6 [hp_X]) Impatiens Glandulifera Flower (7 [hp_X]) Ornithogalum Umbellatum Flowering Top (8 [hp_X]) Passiflora Incarnata Flowering Top (12 [hp_X]) Angelica Sinensis Root Silver Cation Cocoa Lithium Cation Prunus Cerasifera Flower Valerian Macropiper Methysticum Root Sus Scrofa Adrenal Gland Aconitum Napellus Semecarpus Anacardium Juice Arsenic Cation (3+) Oyster Shell Calcium Carbonate, Crude Anamirta Cocculus Seed Strychnos Ignatii Seed Gelsemium Sempervirens Root
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-07-29

Description

Clematis Vitalba, Flos 3X, Helianthemum Nummularium, Flos 3X, Impatiens Glandulifera, Flos 3X, Ornithogalum Umbellatum, Flos 3X, Passiflora Incarnata 3X, Angelica Sinensis 6X, Argentum Nitricum 6X, Cacao 6X, Lithium Carbonicum 6X, Prunus Cerasifera, Flos 6X, Valeriana Officinalis 6X, Piper Methysticum 7X, Glandula Suprarenalis Suis 8X, Aconitum Napellus 12X, Anacardium Orientale 12X, Arsenicum Album 12X, Calcarea Carbonica 12X, Cocculus Indicus 12X, Ignatia Amara 12X, Gelsemium Sempervirens 12X, 30X.


Medication Information

Description

Clematis Vitalba, Flos 3X, Helianthemum Nummularium, Flos 3X, Impatiens Glandulifera, Flos 3X, Ornithogalum Umbellatum, Flos 3X, Passiflora Incarnata 3X, Angelica Sinensis 6X, Argentum Nitricum 6X, Cacao 6X, Lithium Carbonicum 6X, Prunus Cerasifera, Flos 6X, Valeriana Officinalis 6X, Piper Methysticum 7X, Glandula Suprarenalis Suis 8X, Aconitum Napellus 12X, Anacardium Orientale 12X, Arsenicum Album 12X, Calcarea Carbonica 12X, Cocculus Indicus 12X, Ignatia Amara 12X, Gelsemium Sempervirens 12X, 30X.

Warnings:

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

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

Tamper seal: sealed for your protection.

Do not use if seal is broken or missing.

Questions:

Distributed by

Pro Weight Loss Inc., 94 Boylston Cir.

Shrewsbury, MA 01545 • 877-323-0107

Directions:

1-10 drops under the tongue, 3 times a day or as directed by your health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients:

Clematis Vitalba, Flos 3X, Helianthemum Nummularium, Flos 3X, Impatiens Glandulifera, Flos 3X, Ornithogalum Umbellatum, Flos 3X, Passiflora Incarnata 3X, Angelica Sinensis 6X, Argentum Nitricum 6X, Cacao 6X, Lithium Carbonicum 6X, Prunus Cerasifera, Flos 6X, Valeriana Officinalis 6X, Piper Methysticum 7X, Glandula Suprarenalis Suis 8X, Aconitum Napellus 12X, Anacardium Orientale 12X, Arsenicum Album 12X, Calcarea Carbonica 12X, Cocculus Indicus 12X, Ignatia Amara 12X, Gelsemium Sempervirens 12X, 30X.

Inactive Ingredients:

demineralized water, 25% ethanol

Package Label Display:

NDC 70558-0010-1

Pro Weight Loss

HOMEOPATHIC

Calm 

Anxiety and Stress

1 FL OZ (30 ml)

Homeopathic Indications:

For temporary relief of symptoms related to stress including mild anxiousness, worry, overwhelm, and mild fear.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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.


Structured Label Content

Warnings: (WARNINGS:)

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

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

Tamper seal: sealed for your protection.

Do not use if seal is broken or missing.

Questions: (QUESTIONS:)

Distributed by

Pro Weight Loss Inc., 94 Boylston Cir.

Shrewsbury, MA 01545 • 877-323-0107

Directions: (DIRECTIONS:)

1-10 drops under the tongue, 3 times a day or as directed by your health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Clematis Vitalba, Flos 3X, Helianthemum Nummularium, Flos 3X, Impatiens Glandulifera, Flos 3X, Ornithogalum Umbellatum, Flos 3X, Passiflora Incarnata 3X, Angelica Sinensis 6X, Argentum Nitricum 6X, Cacao 6X, Lithium Carbonicum 6X, Prunus Cerasifera, Flos 6X, Valeriana Officinalis 6X, Piper Methysticum 7X, Glandula Suprarenalis Suis 8X, Aconitum Napellus 12X, Anacardium Orientale 12X, Arsenicum Album 12X, Calcarea Carbonica 12X, Cocculus Indicus 12X, Ignatia Amara 12X, Gelsemium Sempervirens 12X, 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

demineralized water, 25% ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

NDC 70558-0010-1

Pro Weight Loss

HOMEOPATHIC

Calm 

Anxiety and Stress

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

For temporary relief of symptoms related to stress including mild anxiousness, worry, overwhelm, and mild fear.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Keep Out of Reach of Children: (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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