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| Product NDC Code | 55714-4798 | ||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Headache-migraine |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vasodilation [PE] |
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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 Apis mellifica 6x, Hypericum perforatum 6x, Thuja occidentalis 6x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Carduus benedictus 15x, Cimicifuga racemosa 15x, Coffea cruda 15x, Convallaria majalis 15x, Crotalus horridus 15x, Digitalis purpurea 15x, Gelsemium sempervirens 15x, Glonoinum 15x, Ignatia amara 15x, Lachesis mutus 15x, Mercurius vivus 15x, Naja tripudians 15x, Nux vomica 15x, Phosphorus 15x, Rhus toxicodendron 15x, Sanguinaria canadensis 15x, Secale cornutum 15x, Vipera berus 15x, Elaps corallinus 30x.
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT SECTION 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 associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE SECTION Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.
Spl product data elements
Usually a list of ingredients in a drug product.Headache-Migraine Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ.. WATER ALCOHOL MICRURUS CORALLINUS VENOM MICRURUS CORALLINUS VENOM ARSENIC TRIOXIDE ARSENIC CATION (3+) ATROPA BELLADONNA ATROPA BELLADONNA BRYONIA ALBA ROOT BRYONIA ALBA ROOT CENTAUREA BENEDICTA CENTAUREA BENEDICTA BLACK COHOSH BLACK COHOSH ARABICA COFFEE BEAN ARABICA COFFEE BEAN CONVALLARIA MAJALIS CONVALLARIA MAJALIS CROTALUS HORRIDUS HORRIDUS VENOM CROTALUS HORRIDUS HORRIDUS VENOM DIGITALIS DIGITALIS LACHESIS MUTA VENOM LACHESIS MUTA VENOM GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT NITROGLYCERIN NITROGLYCERIN STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED MERCURY MERCURY NAJA NAJA VENOM NAJA NAJA VENOM STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PHOSPHORUS PHOSPHORUS TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM VIPERA BERUS VENOM VIPERA BERUS VENOM APIS MELLIFERA APIS MELLIFERA HYPERICUM PERFORATUM HYPERICUM PERFORATUM THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG
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