Label: HEADACHE RELIEF- bryonia alba root - gelsemium sempervirens root - sanguinaria canadensis root - spigelia anthelmia - tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 47242-0081-1 - Packager: Homeostasis Laboratories, Inc.
- 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 November 14, 2012
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ACTIVE INGREDIENT
Active Ingredients Purpose Belladonna 30C, HPUS Relieves throbbing pains Bryonia 30C, HPUS Relieves sharp pains Gelsemium sempervirens 30C, HPUS Relieves heaviness in the head Sanguinaria canadensis 30C, HPUS Relieves pain Spigelia anthelmia 30C, HPUS Relieves pain "HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.
Statement of Identity: Analgesic.
- PURPOSE
- Uses
- Warnings
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
- DO NOT USE
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEADACHE RELIEF
bryonia alba root - gelsemium sempervirens root - sanguinaria canadensis root - spigelia anthelmia - tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47242-0081 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 30 [hp_C] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C] SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 30 [hp_C] SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA 30 [hp_C] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) Product Characteristics Color WHITE Score no score Shape DIAMOND (Rounded) Size 11mm Flavor Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47242-0081-1 1 in 1 PACKAGE 1 50 in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2009 Labeler - Homeostasis Laboratories, Inc. (010569196)