Label: PARASITES- abrotanum, aesculus hipp., allium sativum, arsenicum alb., artemisia, baptisia, cina, cuprum met., filix mas, granatum, ipecac, lachesis, lycopodium, merc. viv, naphthalinum, nat. mur., nux vom., pulsatilla, ratanhia, ruta, sabadilla, santoninum, silicea, spigelia anth., terebinthina, teucrium marum, thymolum, zingiber, juglans regia liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-2304-0, 55714-2304-1, 55714-2304-2 - Packager: Newton Laboratories, 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 March 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
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DOSAGE & ADMINISTRATION SECTION
Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: For severe parasitic infestation or prolonged symptoms, consult a licensed healthcare professional.
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OTC - ACTIVE INGREDIENT SECTION
Abrotanum 15x, Aesculus hipp. 15x, Allium sativum 15x, Arsenicum alb. 15x, Artemisia 15x, Baptisia 15x, Cina 15x, Cuprum met. 15x, Filix mas 15x, Granatum 15x, Ipecac. 15x, Lachesis 15x, Lycopodium 15x, Merc. viv. 15x, Naphthalinum 15x, Nat. mur. 15x, Nux vom. 15x, Pulsatilla 15x, Ratanhia 15x, Ruta 15x, Sabadilla 15x, Santoninum 15x, Silicea 15x, Spigelia anth. 15x, Terebinthina 15x, Teucrium marum 15x, Thymolum 15x, Zingiber 15x, Juglans regia 3x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
PARASITES
abrotanum, aesculus hipp., allium sativum, arsenicum alb., artemisia, baptisia, cina, cuprum met., filix mas, granatum, ipecac, lachesis, lycopodium, merc. viv, naphthalinum, nat. mur., nux vom., pulsatilla, ratanhia, ruta, sabadilla, santoninum, silicea, spigelia anth., terebinthina, teucrium marum, thymolum, zingiber, juglans regia liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2304 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Artemisia Abrotanum Flowering Top (UNII: QG07G580U0) (Artemisia Abrotanum Flowering Top - UNII:QG07G580U0) Artemisia Abrotanum Flowering Top 15 [hp_X] in 1 mL Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ) Horse Chestnut 15 [hp_X] in 1 mL Garlic (UNII: V1V998DC17) (Garlic - UNII:V1V998DC17) Garlic 15 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 15 [hp_X] in 1 mL Artemisia Vulgaris Root (UNII: 32MP823R8S) (Artemisia Vulgaris Root - UNII:32MP823R8S) Artemisia Vulgaris Root 15 [hp_X] in 1 mL Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria 15 [hp_X] in 1 mL Artemisia Maritima Flower (UNII: 6654882GP8) (Artemisia Maritima Flower - UNII:6654882GP8) Artemisia Maritima Flower 15 [hp_X] in 1 mL Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper 15 [hp_X] in 1 mL Dryopteris Filix-mas Root (UNII: C0ZK0RRF5X) (Dryopteris Filix-mas Root - UNII:C0ZK0RRF5X) Dryopteris Filix-mas Root 15 [hp_X] in 1 mL Punica Granatum Root Bark (UNII: CLV24I3T1D) (Punica Granatum Root Bark - UNII:CLV24I3T1D) Punica Granatum Root Bark 15 [hp_X] in 1 mL Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac 15 [hp_X] in 1 mL Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 15 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 15 [hp_X] in 1 mL Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury 15 [hp_X] in 1 mL Naphthalene (UNII: 2166IN72UN) (Naphthalene - UNII:2166IN72UN) Naphthalene 15 [hp_X] in 1 mL Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 15 [hp_X] in 1 mL Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 15 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 15 [hp_X] in 1 mL Krameria Lappacea Root (UNII: P29ZH1A35Z) (Krameria Lappacea Root - UNII:P29ZH1A35Z) Krameria Lappacea Root 15 [hp_X] in 1 mL Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top 15 [hp_X] in 1 mL Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon Officinale Seed 15 [hp_X] in 1 mL Santonin (UNII: 1VL8J38ERO) (Santonin - UNII:1VL8J38ERO) Santonin 15 [hp_X] in 1 mL Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide 15 [hp_X] in 1 mL Spigelia Anthelmia (UNII: WYT05213GE) (Spigelia Anthelmia - UNII:WYT05213GE) Spigelia Anthelmia 15 [hp_X] in 1 mL Turpentine Oil (UNII: C5H0QJ6V7F) (Turpentine Oil - UNII:C5H0QJ6V7F) Turpentine Oil 15 [hp_X] in 1 mL Teucrium Marum (UNII: 10464S0TAA) (Teucrium Marum - UNII:10464S0TAA) Teucrium Marum 15 [hp_X] in 1 mL Thymol (UNII: 3J50XA376E) (Thymol - UNII:3J50XA376E) Thymol 15 [hp_X] in 1 mL Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger 15 [hp_X] in 1 mL English Walnut (UNII: 1V3SHR7QB7) (English Walnut - UNII:1V3SHR7QB7) English Walnut 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2304-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-2304-2 59.14 mL in 1 BOTTLE, GLASS 3 NDC:55714-2304-0 .5 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2304)