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#
Contacts and useful links#
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
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
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4859-1 | Para-Si | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4859 | PARA-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.] | 1 | Current NDC, 1 package rows | 20241127_27d5997b-1cae-41c2-e063-6394a90ac74a.zip |
Products#
Every source-derived product name is available through these pages.
- Para-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
- WATER
- ALCOHOL
- ARTEMISIA ABROTANUM FLOWERING TOP
- HORSE CHESTNUT
- GARLIC
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- 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
- CHLORIDE ION
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4859 | 55714-4859-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Para-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 | Newton Laboratories, Inc. | 27d5997b-1cae-41c2-e063-6394a90ac74a | 2024-11-26 | Warnings | 55714-4859-1 55714-4859 55714485901 27d587ec-b67e-ea05-e063-6394a90a9aac 27d5997b-1cae-41c2-e063-6394a90ac74a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
