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| Product NDC Code | 54973-4008 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Headache relief |
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| Type | Brand | ||||||||
| 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 |
Overdosage of Headache Relief
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Active ingredients Purpose Belladonna 12X HPUS (0.0000000000003% Alkaloids, calculated) headache Gelsemium Sempervirens 6X HPUS headache Ipecacuanha 6X HPUS headache Iris Versicolor 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 Adults and children 12 years and over Dissolve 2 tablets under tongue every 15 minutes up to 4 doses, then every 4 hours until relieved. Children under 12 years Consult a physician.
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 headaches
Purpose
Information about the drug product’s indications for use.Headache Relief
Spl product data elements
Usually a list of ingredients in a drug product.Headache Relief Atropa Belladonna, Gelsemium Sempervirens Root, Ipecac and Iris Versicolor Root ACACIA LACTOSE MONOHYDRATE GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT IPECAC IPECAC ATROPA BELLADONNA ATROPA BELLADONNA IRIS VERSICOLOR ROOT IRIS VERSICOLOR ROOT 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 HOMEOPATHIC NDC 54973-4008-1 SINCE 1903 Hyland's Headache Relief * TOUGH ON PAIN - GENTLE ON YOU NO ACETAMINOPHEN NO IBUPROFEN NO KNOWN DRUG INTERACTIONS 100 QUICK-DISSOLVING TABLETS NATURAL RELIEF *SEE NOTE ON BACK PANEL BELOW DRUG FACTS carton
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 12X HPUS (0.0000000000003% Alkaloids, calculated) headache Gelsemium Sempervirens 6X HPUS headache Ipecacuanha 6X HPUS headache Iris Versicolor 6X HPUS headache "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
*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.Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ new symptoms occur.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use more than directed.
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 this and all medications out of the reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band 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 or comments? (800) 624-9659
Pregnancy or breast feeding
Pregnancy or Breast feedingAs with any drug, ask a doctor before use if pregnant or breast-feeding.
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 As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use more than directed. Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ new symptoms occur. Keep this and all medications out of the reach of children. In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
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