Para-Si

Manufacturer
Newton Laboratories, Inc.
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:29:06

Label at a glance#

ProductPara-Si
Active ingredientARTEMISIA ABROTANUM FLOWERING TOP, HORSE CHESTNUT, GARLIC, ARSENIC TRIOXIDE, ARTEMISIA VULGARIS ROOT, 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, NAPHTHALENE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, ANEMONE PULSATILLA, KRAMERIA LAPPACEA ROOT, RUTA GRAVEOLENS FLOWERING TOP, SCHOENOCAULON OFFICINALE SEED, SANTONIN, SILICON DIOXIDE, SPIGELIA ANTHELMIA, GINGER, TURPENTINE OIL, TEUCRIUM MARUM, THYMOL, JUGLANS REGIA LEAF
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Warning: For severe parasitic infestation or prolonged symptoms, consult a licensed health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Juglans reg 11x, Abrotanum 20x, Aesculus hipp 20x, Allium sat 20x, Arsenicum alb 20x, Artemisia 20x, Baptisia 20x, Cina 20x, Cuprum met 20x, Filix mas 20x, Granatum 20x, Ipecac 20x, Lachesis 20x, Lycopodium 20x, Merc viv 20x, Naphthalinum 20x, Nat mur 20x, Nux vom 20x, Pulsatilla 20x, Ratanhia 20x, Ruta 20x, Sabadilla 20x, Santoninum 20x, Silicea 20x, Spigelia anth 20x, Terebinthina 20x, Teucrium mar 20x, Thymolum 20x, Zingiber 20x.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

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

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4859-1Para-Si30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4859PARA-SI (JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, 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 MAR, THYMOLUM, ZINGIBER) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20241127_27d5997b-1cae-41c2-e063-6394a90ac74a.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-485955714-4859-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

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
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, 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 MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
ndc (package): 55714-4859-1
ndc (product): 55714-4859
ndc11 (package): 55714485901
spl id: 27d587ec-b67e-ea05-e063-6394a90a9aac
spl set id: 27d5997b-1cae-41c2-e063-6394a90ac74a

Reported adverse events (FAERS/openFDA)#

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