Edema 2329P-Dis

Drug Labeling and Warnings

Drug Details [pdf]

EDEMA - FLUID RETENTION- 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 2329P-Dis

INDICATIONS & USAGE SECTION

Edema - Fluid Retention  Formulated for associated symptoms such as skin discoloration, discomfort and swelling due to fluid retention.

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.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Apis mel. 10x, Arsenicum alb. 10x, Cantharis 10x, Cinchona 10x, Colchicum 10x, Convallaria 10x, Crotalus horridus 10x, Digitalis 10x, Juniperus com.10x, Lachesis 10x, Merc. viv. 10x, Naja 10x, Nat. carb. 10x, Nat.sulphuricum 10x, Rhus toxicodendron 10x, Sambucus nig. 10x, Strophanthus hispidus 10x, Thuja occ. 10x, Vipera berus 10x, Echinacea 3x, Lappa 3x, Solidago 3x, Taraxacum 3x, Urtica ur. 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as skin discoloration, discomfort and swelling due to fluid retention.

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.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

EDEMA - FLUID RETENTION 
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 OTC DRUGItem Code (Source)NDC: 55714-2329
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL) JUNIPER BERRY10 [hp_X]  in 1 g
MICRURUS CORALLINUS VENOM (UNII: V0S6H36980) (MICRURUS CORALLINUS VENOM - UNII:V0S6H36980) MICRURUS CORALLINUS VENOM30 [hp_X]  in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]  in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 1 g
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA10 [hp_X]  in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 1 g
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB10 [hp_X]  in 1 g
CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS10 [hp_X]  in 1 g
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM10 [hp_X]  in 1 g
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS10 [hp_X]  in 1 g
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]  in 1 g
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY10 [hp_X]  in 1 g
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM10 [hp_X]  in 1 g
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE10 [hp_X]  in 1 g
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE10 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 1 g
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP10 [hp_X]  in 1 g
STROPHANTHUS HISPIDUS SEED (UNII: MO892VI77K) (STROPHANTHUS HISPIDUS SEED - UNII:MO892VI77K) STROPHANTHUS HISPIDUS SEED10 [hp_X]  in 1 g
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]  in 1 g
VIPERA BERUS VENOM (UNII: 0ORO6NCA4M) (VIPERA BERUS VENOM - UNII:0ORO6NCA4M) VIPERA BERUS VENOM10 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [hp_X]  in 1 g
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT3 [hp_X]  in 1 g
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]  in 1 g
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 g
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2329-128.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
2NDC: 55714-2329-256.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
3NDC: 55714-2329-07.08 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/201101/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2329)

Revised: 1/2019