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| Product NDC Code | 57955-5638 | ||||||||||||||||||||||||||||||||
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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 | King Bio Inc. | ||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM potencies. Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Kali phosphoricum, Ignatia amara, Passiflora incarnata, Phosphorus, Pulsatilla, Valeriana officinalis. HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States. Reference image:Sleep .jpg
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 Initially, depress pump until primed. Spray one dose directly into mouth. Adults: 3 sprays 3 times per day. Children ages 6-12: 2 sprays 3 times per day. Consult a physician for use in children under 6 years of age. Use additionally as needed, up to 6 times per day. Reference image:Sleep .jpg
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides). Reference image:Sleep .jpg
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.Uses Uses for temporary relief of symptoms due to occasional sleeplessness: Restlessness Nervousness Exhaustion Excitability Inability to fall or stay asleep Worry as per various homeopathic materia medicas. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by the FDA, and product has not been clinically tested. Reference image:Sleep .jpg
Purpose
Information about the drug product’s indications for use.Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM potencies. Aconitum napellus ..................................................fear, worry Aesculus hippocastanum, flos............................... heavy eyelids Arsenicum album ...............................................anguish, fears Avena sativa................................................nervous exhaustion Belladonna ............................................................restlessness Camphora .........................................................restless tossing Cinchona officinalis .........................anxious dreams, early waking Coffea cruda..................................................nervous excitability Cypripedium pubescens............................................wakefulness Hyoscyamus niger........................................inability to fall asleep Kali phosphoricum...................................................night terrors Ignatia amara ..................................................light sleep, worry Passiflora incarnata................................restlessness, wakefulness Phosphorus ...........................................................sleeplessness Pulsatilla .................................................irregular sleep patterns Valeriana officinalis..........................................tossing and turning **“HPUS” indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States. Reference image:Sleep .jpg
Spl product data elements
Usually a list of ingredients in a drug product.Sleep Aid Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Kali phosphoricum, Ignatia amara, Passiflora incarnata, Phosphorus, Pulsatilla, Valeriana officinalis. ACONITUM NAPELLUS WHOLE ACONITUM NAPELLUS AESCULUS HIPPOCASTANUM FLOWER AESCULUS HIPPOCASTANUM FLOWER ARSENIC TRIOXIDE ARSENIC CATION (3+) AVENA SATIVA FLOWERING TOP AVENA SATIVA FLOWERING TOP ATROPA BELLADONNA ATROPA BELLADONNA CAMPHOR (NATURAL) CAMPHOR (NATURAL) CINCHONA OFFICINALIS BARK CINCHONA OFFICINALIS BARK ARABICA COFFEE BEAN ARABICA COFFEE BEAN CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT HYOSCYAMUS NIGER HYOSCYAMUS NIGER DIBASIC POTASSIUM PHOSPHATE PHOSPHATE ION STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP PHOSPHORUS PHOSPHORUS PULSATILLA VULGARIS WHOLE ANEMONE PULSATILLA VALERIAN VALERIAN ASCORBIC ACID CITRIC ACID MONOHYDRATE CITRUS AURANTIUM FRUIT OIL ORANGE PEEL CITRUS RETICULATA FRUIT OIL WATER GLYCERIN LACTIC ACID, UNSPECIFIED FORM LONICERA JAPONICA FLOWER BENZYLPENICILLOYL POLYLYSINE CARYA OVATA BARK STEVIOL
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.image description
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. In case of overdose, get medical help or contact a Poison Control Center immediately. Reference image:Sleep .jpg
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Tamper resistant for your protection. Use only if safety seal is intact. Keep carton for complete drug facts and product information. Questions? Call 866.298.2740 King Bio, Inc. 3 Westside Drive Asheville, NC 2806 USA FDA Reg. #1053442 For latest product information and instructions: www.DrKings.com Reference image:Sleep .jpg
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 Stop use and consult a physician if symptoms worsen or persist for more than 7 days. If pregnant or breast-feeding , ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. Reference image:Sleep .jpg
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