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| Product NDC Code | 70558-0011 | ||||||||||||||||||||||||||||||||||||
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| Drug Name | Sleep aid |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||||||||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||||||||||||||||||||||||
| Labeler Name | Pro Weight Loss Inc. | ||||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: demineralized water, 25% ethanol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Sleep Aid Adenosinum Triphosphoricum Dinatrum, Pantothenic Acid, Pineal Gland (Suis), Sarcolacticum Acidum, Ubidecarenonum, L-Tryptophan, Melatonin, Pyrrole, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus (Bach) ADENOSINE TRIPHOSPHATE DISODIUM ADENOSINE TRIPHOSPHATE PANTOTHENIC ACID PANTOTHENIC ACID SUS SCROFA PINEAL GLAND SUS SCROFA PINEAL GLAND LACTIC ACID, L- LACTIC ACID, L- UBIDECARENONE UBIDECARENONE TRYPTOPHAN TRYPTOPHAN MELATONIN MELATONIN PYRROLE PYRROLE ARSENIC TRIOXIDE ARSENIC CATION (3+) AVENA SATIVA FLOWERING TOP AVENA SATIVA FLOWERING TOP MATRICARIA CHAMOMILLA WHOLE MATRICARIA CHAMOMILLA ARABICA COFFEE BEAN ARABICA COFFEE BEAN MERCURIC CHLORIDE MERCURIC CATION PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP SILICON DIOXIDE SILICON DIOXIDE ZINC VALERATE DIHYDRATE VALERIC ACID SHIGELLA DYSENTERIAE SHIGELLA DYSENTERIAE SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS WATER ALCOHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL DISPLAY: NDC 70558-0011-1 Pro Weight Loss HOMEOPATHIC Sleep Aid 1 FL OZ (30 ml) Sleep Aid
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS: Distributed by Pro Weight Loss Inc., 94 Boylston Cir. Shrewsbury, MA 01545 • 877-323-0107
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API