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| Product NDC Code | 55714-2471 | ||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Jet lag |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [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 | Newton Laboratories, Inc. | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.OTC - ACTIVE INGREDIENT SECTION Equal parts of Echinacea 6x, Alumina 15x, Aralia quinquefolia 15x, Argentum nitricum 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Conium maculatum 15x, Gelsemium sempervirens 15x, Iodium 15x, Kali carbonicum 15x, Kali iodatum 15x, Lycopodium clavatum 15x, Lycopus virginicus 15x, Natrum muriaticum 15x, Nux vomica 15x, Phosphorus 15x, Phytolacca decandra 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sabal serrulata 15x, Thyroidinum 15x.
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.DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT SECTION Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
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.INDICATIONS & USAGE SECTION Formulated for symptoms associated with travel and time change such as fatigue, sleeplessness, headaches, vomiting, cramping and other related symptoms.
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE SECTION Formulated for symptoms associated with travel and time change such as fatigue, sleeplessness, headaches, vomiting, cramping and other related symptoms.
Spl product data elements
Usually a list of ingredients in a drug product.Jet Lag Echinacea, Alumina, Aralia quinquefolia, Argentum, Arnica montana, Arsenicum album, Baptisia tinctoria, Bryonia, Cantharis, Chelidonium majus, Conium maculatum, Gelsemium sempervirens, Iodium, Kali carbonicum, Kali iodatum, Lycopodium clavatum, Lycopus virginicus, Natrum muriaticum, Nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhus toxicodendron, Sabal serrulata, Thyroidinum. ALCOHOL ECHINACEA, UNSPECIFIED ECHINACEA, UNSPECIFIED AMERICAN GINSENG AMERICAN GINSENG SILVER NITRATE SILVER CATION ARNICA MONTANA ARNICA MONTANA ARSENIC TRIOXIDE ARSENIC CATION (3+) BAPTISIA TINCTORIA ROOT BAPTISIA TINCTORIA ROOT BRYONIA ALBA ROOT BRYONIA ALBA ROOT LYTTA VESICATORIA LYTTA VESICATORIA CHELIDONIUM MAJUS CHELIDONIUM MAJUS CONIUM MACULATUM FLOWERING TOP CONIUM MACULATUM FLOWERING TOP GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT IODINE IODINE POTASSIUM CARBONATE CARBONATE ION POTASSIUM IODIDE IODIDE ION LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE LYCOPUS VIRGINICUS LYCOPUS VIRGINICUS SODIUM CHLORIDE SODIUM CATION STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PHOSPHORUS PHOSPHORUS PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT ANEMONE PULSATILLA ANEMONE PULSATILLA TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SAW PALMETTO SAW PALMETTO ALUMINUM OXIDE ALUMINUM OXIDE WATER THYROID, UNSPECIFIED THYROID, UNSPECIFIED
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 package label
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.OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS SECTION newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
Pregnancy or breast feeding
Pregnancy or Breast feedingOTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding , ask a doctor before use.
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 SECTION WARNINGS: Keep out of reach of children . Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.
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