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| Product NDC Code | 54973-4030 | ||||||||||||
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| Drug Name | Migraine relief |
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| Type | Brand | ||||||||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vasodilation [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||
| Dosage Form | TABLET | ||||||||||||
| Labeler Name | Hyland's Inc | ||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Active ingredients Purpose Belladonna 6X HPUS (0.0000003% Alkaloids, calculated) pounding pain, light and noise sensitivity Gelsemium 6X HPUS dull headache Glonoinum 12X HPUS throbbing headache, dizziness Iris Versicolor 6X HPUS headache, blurred vision, nausea Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated) frontal headache, dizziness Sanguinaria Canadensis 6X HPUS headache "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
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 ■ Use as directed. Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. Children under 12 years of age Ask a doctor before use.
| Adults and children 12 years and over | At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. |
| Children under 12 years of age | Ask a doctor before use. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acacia Gum, Lactose.
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 ■ Temporarily relieves symptoms of adult migraine headaches including: ■ throbbing headache ■ pounding pain ■ dull headache ■ frontal headache ■ light sensitivity ■ noise sensitivity ■ dizziness ■ nausea ■ blurred vision
Purpose
Information about the drug product’s indications for use.Migraine Relief
Spl product data elements
Usually a list of ingredients in a drug product.Migraine Relief Gelsemium Sempervirens Root, Strychnos Nux-Vomica Seed, Iris Versicolor Root, Sanguinaria Canadensis Root, Atropa Belladonna and Nitroglycerin ACACIA LACTOSE MONOHYDRATE NITROGLYCERIN NITROGLYCERIN GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT IRIS VERSICOLOR ROOT IRIS VERSICOLOR ROOT STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED ATROPA BELLADONNA ATROPA BELLADONNA White to Off White
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.PRINCIPAL DISPLAY PANEL Hyland's NATURALS MIGRAINE RELIEF* TOUGH ON PAIN - GENTLE ON YOU NO Acetaminophen NO Ibruprofen NO Known Drug Interactions NO Caffeine 100 QUICK - DISSOLVING TABLETS HOMEOPATHIC Carton
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Indications and Usage Uses removed extra bullets
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts Active ingredients Active ingredients Purpose Belladonna 6X HPUS (0.0000003% Alkaloids, calculated) pounding pain, light and noise sensitivity Gelsemium 6X HPUS dull headache Glonoinum 12X HPUS throbbing headache, dizziness Iris Versicolor 6X HPUS headache, blurred vision, nausea Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated) frontal headache, dizziness Sanguinaria Canadensis 6X HPUS headache "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Drug Facts (continued) Inactive ingredients Acacia Gum, Lactose. Questions? www.hylands.com or [email protected]
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have ■ never had migraines diagnosed by a health professional. ■ a headache that is different from your usual migraines. ■ the worst headache of your life. ■ fever and stiff neck. ■ headaches beginning after or caused by head injury, exertion, coughing or bending. ■ experienced your first headache after the age of 50. ■ daily headaches. a migraine so severe as to require bed rest. ■ been vomiting with your migraine headache.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? www.hylands.com or [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ■ an allergic reaction occurs. ■ you feel faint. ■ your migraine is not relieved or worsens after first dose. ■ new or unexpected symptoms occur. ■ ringing in the ears or loss of hearing occurs.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding Ask a health professional 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 Ask a doctor before use if you have ■ never had migraines diagnosed by a health professional. ■ a headache that is different from your usual migraines. ■ the worst headache of your life. ■ fever and stiff neck. ■ headaches beginning after or caused by head injury, exertion, coughing or bending. ■ experienced your first headache after the age of 50. ■ daily headaches. a migraine so severe as to require bed rest. ■ been vomiting with your migraine headache. Stop use and ask a doctor if ■ an allergic reaction occurs. ■ you feel faint. ■ your migraine is not relieved or worsens after first dose. ■ new or unexpected symptoms occur. ■ ringing in the ears or loss of hearing occurs. If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children.
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