FIBROMYALGIA REAL RELIEF- calcarea phosphorica, ignatia amara, causticum, rhus toxicodendron, magnesia phosphorica, bryonia, arnica montana tablet, chewable 
HOMEOLAB USA INC

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.

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DRUG FACTS

ACTIVE INGREDIENTS HPUS

Calcarea phosphorica (Tribasic calcium phosphate) 7C
Ignatia amara (Ignatius bean) 9C
Causticum (Causticum) 7C
Rhus toxicodendron (Poison ivy) 7C
Magnesia phosphorica (Magnesium hydrogen phosphate) 7C
Bryonia (White bryony) 7C
Arnica montana (Leopard's bane) 9C


The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

fatigue, stiffness
pain and stiffness, restless sleep
pain and stiffness
fatigue, pain and sleeplessness
pain and fatigue, restless sleep
sleeplessness, pain and stiffness
pain and sleeplessness

USES

This homeopathic medicine helps relieve symptoms associated with fibromialgia:

- pain

- fatigue

- stiffness

- insomnia

WARNINGS


Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

DIRECTIONS

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 3 times daily and reduce intake with improvement or as directed by a health professional.


Age
 Dose
Adults and children 12 years of age and older2 tablets
Children under 12 years of age
Ask a doctor



OTHER INFORMATION

Store at room temperature (68 - 77F).

Do not use if seal is broken or missing.

INACTIVE INGREDIENTS

Lactose, magnesium stearate.


CARTON

image of carton label

FIBROMYALGIA  REAL RELIEF
calcarea phosphorica, ignatia amara, causticum, rhus toxicodendron, magnesia phosphorica, bryonia, arnica montana tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) PHOSPHATE ION7 [hp_C]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED9 [hp_C]
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM7 [hp_C]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF7 [hp_C]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION7 [hp_C]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT7 [hp_C]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA9 [hp_C]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-6015-090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/25/2012
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(60512-6015)

Revised: 11/2012
Document Id: 6b43f8e8-80da-47a9-80ea-cc70f683028f
Set id: f0fb8884-2707-4ec5-ac5e-632c9c452d8d
Version: 2
Effective Time: 20121121
 
HOMEOLAB USA INC