Label: MIGRAINE HEADACHE THERAPY- atropa belladonna - bryonia alba root - black cohosh - arabica coffee bean - nitroglycerin - iris versicolor root - sodium chloride - tablet, orally disintegrating
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Contains inactivated NDC Code(s)
NDC Code(s): 17312-022-14 - Packager: TRP Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated August 4, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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.
- PURPOSE
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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
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children
- WARNINGS
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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.
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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
- Do not use if tamper evident seal is torn, broken or missing.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIGRAINE HEADACHE THERAPY
atropa belladonna - bryonia alba root - black cohosh - arabica coffee bean - nitroglycerin - iris versicolor root - sodium chloride - tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17312-022 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 6 [hp_X] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 6 [hp_X] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [hp_X] NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 12 [hp_X] IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 6 [hp_X] SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] Inactive Ingredients Ingredient Name Strength MANNITOL (UNII: 3OWL53L36A) SORBITOL (UNII: 506T60A25R) CROSPOVIDONE (UNII: 68401960MK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) COPOVIDONE (UNII: D9C330MD8B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape DIAMOND Size 13mm Flavor Imprint Code TRP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17312-022-14 1 in 1 PACKAGE 1 70 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2011 Labeler - TRP Company (105185719)