FDA Label for Migraine Headache Therapy

View Indications, Usage & Precautions

Migraine Headache Therapy Product Label

The following document was submitted to the FDA by the labeler of this product Trp Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active IngredientsPurpose
Belladonna HPUS6x, 12xPounding, Throbbing Headache
Bryonia HPUS6x, 12x, 18xPressure Headache, Vertigo
Cimicifuga racemosa HPUS6x, 12x, 18xLightheadedness
Coffea crudaHPUS 3xIntolerable Pain, Sensitivity
Glonoinum HPUS12x, 18xBursting Headache, Vertigo
Iris versicolor HPUS6x, 12x, 18xSick Headache, Nausea
Natrum muriaticum HPUS6x, 12x, 18xBlinding Headache, Blurred Vision

"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.


Indications & Usage



Uses:*
According to homeopathic indications, these ingredients provide temporary relief for symptoms such as: • Pressure • Throbbing • Light and noise sensitivity after diagnosis by a physician.
*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.


Warnings



Warnings:

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.

  • This product is intended to complement, not replace, standard medical treatment.
  • Initial worsening of symptoms may occur.
  • A physician should always be consulted to rule out serious causes.
    • In case of overdose, get medical help or contact a Poison Control Center right away.
    • Stop use and ask a doctor if:

      • You experience worsening symptoms.
      • If symptoms last longer than 7 days.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Directions



  • Suitable for adults and children 12 years and above.
  • Dissolve entire tablet under tongue.
  • Do not chew or swallow whole.
  • Take 1 tablet 3 times a day or as directed by a physician.
  • Use up to 6 times a day as needed.
  • Take at least 10 minutes before or at least 10 minutes after eating or drinking.
  • Children under the age of 12: consult a physician before use.
  • May take up to 60 days to see results.
  • Homeopathic remedies may not be effective for everyone.

Other Information



  • There are no known contraindications.
  • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
  • Store in a cool dark location.
  • Migraine Headache Therapy™ Homeopathic Fast Dissolving Tablet are homeopathic dilutions: see www.thereliefproducts.com for details.

Inactive Ingredients



Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.


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