Label: HENDEL FIBROMYALGIA SYMPTOM RELIEF- valerian, arnica montana root, aconitum napellus, bryonia alba root,toxicodendron pubescens leaf, berberis vulgaris root bark, colchicum autumnale bulb, solanum dulcamara top, harpagophytum procumbens whole, rhododendron tomentosum leafy twig, and rhododendron aureum leaf tablet
- NDC Code(s): 62795-1117-2
- Packager: MediNatura 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 April 17, 2018
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WARNINGS
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Fibromyalgia Symptom Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.
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INGREDIENTS AND APPEARANCE
HENDEL FIBROMYALGIA SYMPTOM RELIEF
valerian, arnica montana root, aconitum napellus, bryonia alba root,toxicodendron pubescens leaf, berberis vulgaris root bark, colchicum autumnale bulb, solanum dulcamara top, harpagophytum procumbens whole, rhododendron tomentosum leafy twig, and rhododendron aureum leaf tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62795-1117 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 2 [hp_X] ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 3 [hp_X] ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 4 [hp_X] TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 4 [hp_X] BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 6 COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB 6 [hp_X] SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 6 [hp_X] HARPAGOPHYTUM PROCUMBENS WHOLE (UNII: BY51E8JN4B) (HARPAGOPHYTUM PROCUMBENS WHOLE - UNII:BY51E8JN4B) HARPAGOPHYTUM PROCUMBENS WHOLE 6 [hp_X] RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG 6 [hp_X] RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF 6 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code LEAFMAN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62795-1117-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2016 Labeler - MediNatura Inc (079324099) Establishment Name Address ID/FEI Business Operations MediNatura Inc 102783016 manufacture(62795-1117)
