Migraine Headache Therapy Tablet, Orally Disintegrating
FDA Label NDC 17312-041

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trp Company for the product Migraine Headache Therapy (NDC 17312-041). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - pregnancy or breast feeding, directions, other information, inactive ingredients, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Indications & Usage

→ Warnings

→ Otc - Pregnancy Or Breast Feeding

→ Directions

→ Other Information

→ Inactive Ingredients

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredients		Purpose
Belladonna HPUS	6x, 12x	Pounding, Throbbing Headache
Bryonia HPUS	6x, 12x, 18x	Pressure Headache, Vertigo
Cimicifuga racemosa HPUS	6x, 12x, 18x	Lightheadedness
Coffea cruda	HPUS 3x	Intolerable Pain, Sensitivity
Glonoinum HPUS	12x, 18x	Bursting Headache, Vertigo
Iris versicolor HPUS	6x, 12x, 18x	Sick Headache, Nausea
Natrum muriaticum HPUS	6x, 12x, 18x	Blinding 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.

Otc - Questions

Questions or comments? www.thereliefproducts.com, 1-888-969-6855

Package Label.Principal Display Panel

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