Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID d0af311a-e975-4236-8c0e-0418efa7e45f
Route
ORAL
Published
Effective Date 2021-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Adenosine Triphosphate (8 [hp_X]) Pantothenic Acid (10 [hp_X]) Sus Scrofa Pineal Gland (30 [hp_C]) Lactic Acid, L- Ubidecarenone Tryptophan Melatonin Pyrrole Arsenic Cation (3+) Avena Sativa Flowering Top Matricaria Chamomilla Arabica Coffee Bean Mercuric Cation Passiflora Incarnata Flowering Top Silicon Dioxide Valeric Acid Shigella Dysenteriae Salmonella Enterica Enterica Serovar Enteritidis
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-07-16

Description

Adenosinum Triphosphoricum Dinatrum 8X, Pantothenic Acid 8X, Pineal Gland (Suis) 8X, Sarcolacticum Acidum 8X, Ubidecarenonum 8X, L-Tryptophan, Melatonin 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Pyrrole 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C , Arsenicum Album 10X, 30X, 1LM, Avena Sativa 10X, 30X, 1LM, Chamomilla 10X, 30X, 1LM, Coffea Cruda 10X, 30X, 1LM, Mercurius Corrosivus 10X, 30X, 1LM, Passiflora Incarnata 10X, 30X, 1LM, Silicea 10X, 30X, 1LM, Zincum Valerianicum 10X, 30X, 1LM, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C.


Medication Information

Description

Adenosinum Triphosphoricum Dinatrum 8X, Pantothenic Acid 8X, Pineal Gland (Suis) 8X, Sarcolacticum Acidum 8X, Ubidecarenonum 8X, L-Tryptophan, Melatonin 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Pyrrole 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C , Arsenicum Album 10X, 30X, 1LM, Avena Sativa 10X, 30X, 1LM, Chamomilla 10X, 30X, 1LM, Coffea Cruda 10X, 30X, 1LM, Mercurius Corrosivus 10X, 30X, 1LM, Passiflora Incarnata 10X, 30X, 1LM, Silicea 10X, 30X, 1LM, Zincum Valerianicum 10X, 30X, 1LM, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C.

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:

Adenosinum Triphosphoricum Dinatrum 8X, Pantothenic Acid 8X, Pineal Gland (Suis) 8X, Sarcolacticum Acidum 8X, Ubidecarenonum 8X, L-Tryptophan, Melatonin 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Pyrrole 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C , Arsenicum Album 10X, 30X, 1LM, Avena Sativa 10X, 30X, 1LM, Chamomilla 10X, 30X, 1LM, Coffea Cruda 10X, 30X, 1LM, Mercurius Corrosivus 10X, 30X, 1LM, Passiflora Incarnata 10X, 30X, 1LM, Silicea 10X, 30X, 1LM, Zincum Valerianicum 10X, 30X, 1LM, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C.

Inactive Ingredients:

demineralized water, 25% ethanol

Package Label Display:

NDC 70558-0011-1

Pro Weight Loss

HOMEOPATHIC

Sleep Aid

1 FL OZ (30 ml)

Homeopathic Indications:

For temporary relief of the symptoms of sleeplessness such as tiredness, fatigue, and lack of energy.**

**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:)

Adenosinum Triphosphoricum Dinatrum 8X, Pantothenic Acid 8X, Pineal Gland (Suis) 8X, Sarcolacticum Acidum 8X, Ubidecarenonum 8X, L-Tryptophan, Melatonin 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Pyrrole 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C , Arsenicum Album 10X, 30X, 1LM, Avena Sativa 10X, 30X, 1LM, Chamomilla 10X, 30X, 1LM, Coffea Cruda 10X, 30X, 1LM, Mercurius Corrosivus 10X, 30X, 1LM, Passiflora Incarnata 10X, 30X, 1LM, Silicea 10X, 30X, 1LM, Zincum Valerianicum 10X, 30X, 1LM, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

demineralized water, 25% ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

NDC 70558-0011-1

Pro Weight Loss

HOMEOPATHIC

Sleep Aid

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

For temporary relief of the symptoms of sleeplessness such as tiredness, fatigue, and lack of energy.**

**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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