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

Hendel Fibromyalgia Symptom Relief by

Drug Labeling and Warnings

Hendel Fibromyalgia Symptom Relief by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS

Fibromyalgia Symptom Relief

INGREDIENTS

Each tablet contains equal parts of Valeriana officinalis 2X; Arnica montana,radix 3X, 6X; Aconitum napellus 4X; Bryonia4X; Rhus tox 4X, 8X, 12X, 30X; Berberis vulgaris 6X; Colchicum autumnale 6X; Dulcamara6X, Harpagophytum 6X; Ledum palustre 6X; Rhododendron chrysanthum 6X

INACTIVE INGREDIENT

Lactose, Magnesium stearate

DIRECTIONS

Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician

USES

For the temporary relief of:

Fatigue
Muscle Pain
Sleeplessness

PRINCIPAL DISPLAY PANEL

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 tablet

Product 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)