EDEMA - elaps corallinus , apis mel., arsenicum alb. , cantharis, cinchona , colchicum , convallaria , crotalus horridus , digitalis , juniperus com , lachesis , merc. viv. , naja , nat. carb. , nat. sulphuricum , rhus toxicodendron , sambucus nig. , strophanthus hispidus , thuja occ. , vipera berus , echinacea , lappa , solidago , taraxacum , urtica ur. pellet 
Newton Laboratories, 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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Edema

INDICATIONS & USAGE SECTION

Edema  Formulated for symptoms associated with generalized or peripheral edema due to injury or various health conditions.      

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.                        

ACTIVE INGREDIENT SECTION

Elaps corallinus 35x, Apis mel.15x, Arsenicum alb. 15x, Cantharis 15x, Cinchona 15x, Colchicum 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Juniperus com 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Rhus toxicodendron 15x, Sambucus nig. 15x, Strophanthus hispidus 15x, Thuja occ. 15x, Vipera berus 15x, Echinacea 8x, Lappa 8x, Solidago 8x, Taraxacum 8x, Urtica ur. 8x, Echinacea 3x, Lappa 3x, Solidago 3x, Taraxacum 3x, Urtica ur. 3x.           

PURPOSE SECTION

Formulated for symptoms associated with generalized or peripheral edema due to injury or various health conditions.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Gluten-free, non-GMO, beet-derived sucrose pellets.               

QUESTIONS? SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256          

WARNINGS SECTION

Warning:  Do not use if tamper - evident seal is broken or missing.  Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.  Keep out of reach of children. 

PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.              

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.         

PACKAGE LABEL

package label

EDEMA  
elaps corallinus , apis mel., arsenicum alb. , cantharis, cinchona , colchicum , convallaria , crotalus horridus , digitalis , juniperus com , lachesis , merc. viv. , naja , nat. carb. , nat. sulphuricum , rhus toxicodendron , sambucus nig. , strophanthus hispidus , thuja occ. , vipera berus , echinacea , lappa , solidago , taraxacum , urtica ur. pellet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4543
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom35 [hp_X]  in 1 g
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera15 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 g
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria15 [hp_X]  in 1 g
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark15 [hp_X]  in 1 g
Colchicum Autumnale Bulb (UNII: 993QHL78E6) (Colchicum Autumnale Bulb - UNII:993QHL78E6) Colchicum Autumnale Bulb15 [hp_X]  in 1 g
Convallaria Majalis (UNII: QHH4HVF5QE) (Convallaria Majalis - UNII:QHH4HVF5QE) Convallaria Majalis15 [hp_X]  in 1 g
Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom15 [hp_X]  in 1 g
Digitalis (UNII: F1T8QT9U8B) (Digitalis - UNII:F1T8QT9U8B) Digitalis15 [hp_X]  in 1 g
Juniperus Communis Fruit (UNII: O84B5194RL) (Juniperus Communis Fruit - UNII:O84B5194RL) Juniperus Communis Fruit15 [hp_X]  in 1 g
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 g
Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury15 [hp_X]  in 1 g
Naja Naja Venom (UNII: ZZ4AG7L7VM) (Naja Naja Venom - UNII:ZZ4AG7L7VM) Naja Naja Venom15 [hp_X]  in 1 g
Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D) Sodium Carbonate15 [hp_X]  in 1 g
Sodium Sulfate (UNII: 0YPR65R21J) (Sodium Sulfate Anhydrous - UNII:36KCS0R750) Sodium Sulfate15 [hp_X]  in 1 g
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 g
Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U) Sambucus Nigra Flowering Top15 [hp_X]  in 1 g
Strophanthus Hispidus Seed (UNII: MO892VI77K) (Strophanthus Hispidus Seed - UNII:MO892VI77K) Strophanthus Hispidus Seed15 [hp_X]  in 1 g
Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig15 [hp_X]  in 1 g
Vipera Berus Venom (UNII: 0ORO6NCA4M) (Vipera Berus Venom - UNII:0ORO6NCA4M) Vipera Berus Venom15 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified8 [hp_X]  in 1 g
Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root8 [hp_X]  in 1 g
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top8 [hp_X]  in 1 g
Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale8 [hp_X]  in 1 g
Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens8 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4543-128.35 g in 1 BOTTLE, GLASS
2NDC:55714-4543-256.7 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4543)

Revised: 6/2011
Document Id: 348f1453-cf15-7ab3-749f-ff983025085d
Set id: d090426e-7b68-c0f1-3105-bb911e642576
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.