MedPath

Para-Si

Parasites

Approved
Approval ID

abb28a3b-08f8-46bc-b4d5-957e354fad11

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

Sep 8, 2025

Manufacturers
FDA

Newton Laboratories, Inc.

DUNS: 788793610

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

artemisia abrotanum flowering top, horse chestnut, garlic, arsenic trioxide, artemisia vulgaris root, baptisia tinctoria root, artemisia cina flower, copper, dryopteris filix-mas root, punica granatum root bark, ipecac, lachesis muta venom, lycopodium clavatum spore, mercury, naphthalene, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, krameria lappacea root, ruta graveolens flowering top, schoenocaulon officinale seed, santonin, silicon dioxide, spigelia anthelmia, turpentine oil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55714-4298
Product Classification
G
Generic Name
artemisia abrotanum flowering top, horse chestnut, garlic, arsenic trioxide, artemisia vulgaris root, baptisia tinctoria root, artemisia cina flower, copper, dryopteris filix-mas root, punica granatum root bark, ipecac, lachesis muta venom, lycopodium clavatum spore, mercury, naphthalene, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, krameria lappacea root, ruta graveolens flowering top, schoenocaulon officinale seed, santonin, silicon dioxide, spigelia anthelmia, turpentine oil
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2025
FDA Product Classification

INGREDIENTS (30)

Artemisia Abrotanum Flowering TopActive
Quantity: 15 [hp_X] in 1 mL
Code: QG07G580U0
Classification: ACTIB
Horse ChestnutActive
Quantity: 15 [hp_X] in 1 mL
Code: 3C18L6RJAZ
Classification: ACTIB
GarlicActive
Quantity: 15 [hp_X] in 1 mL
Code: V1V998DC17
Classification: ACTIB
Arsenic TrioxideActive
Quantity: 15 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
Artemisia Vulgaris RootActive
Quantity: 15 [hp_X] in 1 mL
Code: 32MP823R8S
Classification: ACTIB
Baptisia Tinctoria RootActive
Quantity: 15 [hp_X] in 1 mL
Code: 5EF0HWI5WU
Classification: ACTIB
Artemisia Cina FlowerActive
Quantity: 15 [hp_X] in 1 mL
Code: 28M1820ACT
Classification: ACTIB
CopperActive
Quantity: 15 [hp_X] in 1 mL
Code: 789U1901C5
Classification: ACTIB
Dryopteris Filix-mas RootActive
Quantity: 15 [hp_X] in 1 mL
Code: C0ZK0RRF5X
Classification: ACTIB
Punica Granatum Root BarkActive
Quantity: 15 [hp_X] in 1 mL
Code: CLV24I3T1D
Classification: ACTIB
IpecacActive
Quantity: 15 [hp_X] in 1 mL
Code: 62I3C8233L
Classification: ACTIB
Lachesis Muta VenomActive
Quantity: 15 [hp_X] in 1 mL
Code: VSW71SS07I
Classification: ACTIB
Lycopodium Clavatum SporeActive
Quantity: 15 [hp_X] in 1 mL
Code: C88X29Y479
Classification: ACTIB
MercuryActive
Quantity: 15 [hp_X] in 1 mL
Code: FXS1BY2PGL
Classification: ACTIB
NaphthaleneActive
Quantity: 15 [hp_X] in 1 mL
Code: 2166IN72UN
Classification: ACTIB
Sodium ChlorideActive
Quantity: 15 [hp_X] in 1 mL
Code: 451W47IQ8X
Classification: ACTIB
Strychnos Nux-vomica SeedActive
Quantity: 15 [hp_X] in 1 mL
Code: 269XH13919
Classification: ACTIB
Pulsatilla VulgarisActive
Quantity: 15 [hp_X] in 1 mL
Code: I76KB35JEV
Classification: ACTIB
Krameria Lappacea RootActive
Quantity: 15 [hp_X] in 1 mL
Code: P29ZH1A35Z
Classification: ACTIB
Ruta Graveolens Flowering TopActive
Quantity: 15 [hp_X] in 1 mL
Code: N94C2U587S
Classification: ACTIB
Schoenocaulon Officinale SeedActive
Quantity: 15 [hp_X] in 1 mL
Code: 6NAF1689IO
Classification: ACTIB
SantoninActive
Quantity: 15 [hp_X] in 1 mL
Code: 1VL8J38ERO
Classification: ACTIB
Silicon DioxideActive
Quantity: 15 [hp_X] in 1 mL
Code: ETJ7Z6XBU4
Classification: ACTIB
Spigelia AnthelmiaActive
Quantity: 15 [hp_X] in 1 mL
Code: WYT05213GE
Classification: ACTIB
Turpentine OilActive
Quantity: 15 [hp_X] in 1 mL
Code: C5H0QJ6V7F
Classification: ACTIB
Teucrium MarumActive
Quantity: 15 [hp_X] in 1 mL
Code: 10464S0TAA
Classification: ACTIB
ThymolActive
Quantity: 15 [hp_X] in 1 mL
Code: 3J50XA376E
Classification: ACTIB
GingerActive
Quantity: 15 [hp_X] in 1 mL
Code: C5529G5JPQ
Classification: ACTIB
Juglans Regia LeafActive
Quantity: 3 [hp_X] in 1 mL
Code: 85HKB87105
Classification: ACTIB
AlcoholInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/8/2025

PACKAGE LABEL

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/8/2025

PRODUCT NAME & INDICATIONS SECTION

Formulated for symptoms such as bloating, anal itching, skin eruptions, diarrhea, constipation, vomiting and weight loss.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/24/2019

DIRECTION SECTION

Pets, under 50 lbs., give 3 drops by mouth (50 to 500 lbs. - 6 drops, over 500 lbs. - 1/2 teaspoon) one to four times daily or as directed by a health professional. Place in mouth or purified water.Warning: For severe parasitic infestation or prolonged symptoms, consult a licensed health professional.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/8/2025

ACTIVE INGREDIENT SECTION

Equal parts of Juglans reg 6x, Abrotanum 15x, Aesculus hipp 15x, Allium sat 15x, Arsenicum alb 15x, Artemisia 15x, Baptisia 15x, Cina 15x, Cuprum met15x, Filix mas 15x, Granatum 15x, Ipecac 15x, Lachesis 15x, Lycopodium 15x, Merc viv 15x, Naphthalinum 15x, Nat mur 15x, Nux vom15x, Pulsatilla 15x, Ratanhia 15x, Ruta 15x, Sabadilla 15x, Santoninum 15x, Silicea 15x, Spigelia anth 15x, Terebinthina 15x,Teucrium mar 15x, Thymolum 15x, Zingiber 15x.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/31/2019

INACTIVE INGREDIENTS SECTION

USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/24/2019

QUESTIONS SECTION

newtonlabs.net -Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013


WARNINGS SECTION

LOINC: 34071-1Updated: 10/3/2019

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not useif 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,**as a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 7/31/2019

PREGNANCY OR BREAST FEEDING SECTION

Ifpregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/31/2019

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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