FDA.reportPublic FDA data

Parasites

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:45:11

Label at a glance#

ProductParasites
Active ingredientJUGLANS REGIA LEAF, SPIGELIA ANTHELMIA, THYMOL, GARLIC, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, ARTEMISIA CINA PRE-FLOWERING TOP, COPPER, DRYOPTERIS FILIX-MAS ROOT, PUNICA GRANATUM ROOT BARK, IPECAC, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MERCURY, ARTEMISIA ABROTANUM FLOWERING TOP, NAPHTHALENE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, ANEMONE PULSATILLA, KRAMERIA LAPPACEA ROOT, RUTA GRAVEOLENS FLOWERING TOP, SCHOENOCAULON OFFICINALE SEED, SANTONIN, HORSE CHESTNUT, SILICON DIOXIDE, TURPENTINE OIL, GINGER, TEUCRIUM MARUM, ARTEMISIA VULGARIS ROOT
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping, sluggish elimination and other related symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose. Warning: For severe parasitic infestation or prolonged symptoms, consult a licensed health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Juglans regia 6x, Abrotanum 15x, Aesculus hippocastanum 15x, Allium sativum 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Baptisia tinctoria 15x, Cina 15x, Cuprum metallicum 15x, Filix mas 15x, Granatum 15x, Ipecacuanha 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Mercurius vivus 15x, Naphthalinum 15x, Natrum muriaticum 15x, Nux vomica 15x, Pulsatilla 15x, Ratanhia 15x, Ruta graveolens 15x, Sabadilla 15x, Santoninum 15x, Silicea 15x, Spigelia anthelmia 15x, Terebinthina 15x, Teucrium marum 15x, Thymolum 15x, Zingiber officinale 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping, sluggish elimination and other related symptoms.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2496-12025-05-08C16284748780-12cef2736-92c8-d83d-e063-dadaa90ab31fParasites 2496P
55714-2496-12025-01-30C16284748780-12cef2736-92c8-d83d-e063-dadaa90ab31fParasites 2496P

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-249655714-2496-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
JUGLANS REGIA LEAF85HKB87105ACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
THYMOL3J50XA376EACTIB
GARLICV1V998DC17ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ARTEMISIA CINA PRE-FLOWERING TOP28M1820ACTACTIB
COPPER789U1901C5ACTIB
DRYOPTERIS FILIX-MAS ROOTC0ZK0RRF5XACTIB
PUNICA GRANATUM ROOT BARKCLV24I3T1DACTIB
IPECAC62I3C8233LACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURYFXS1BY2PGLACTIB
ARTEMISIA ABROTANUM FLOWERING TOPQG07G580U0ACTIB
NAPHTHALENE2166IN72UNACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
KRAMERIA LAPPACEA ROOTP29ZH1A35ZACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
SANTONIN1VL8J38EROACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
TURPENTINE OILC5H0QJ6V7FACTIB
GINGERC5529G5JPQACTIB
TEUCRIUM MARUM10464S0TAAACTIB
ARTEMISIA VULGARIS ROOT32MP823R8SACTIB
SUCROSEC151H8M554IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
34a2e8a1-a929-621d-e063-6294a90a7e229c972805-dfb8-b405-e053-2995a90a536e2025-05-08WarningsExact identifier
spl set id: 9c972805-dfb8-b405-e053-2995a90a536e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.