Para-Si
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2024-11-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:29:05
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, sluggish elimination and other related symptoms.
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. Sensitive persons begin with 1 drop 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 reg 6x, Abrotanum 15x, Aesculus hipp 15x, Allium sat 15x, Arsenicum alb 15x, Artemisia 15x, Baptisia 15x, Cina 15x, Cuprum met 15x, Filix mas 15x, Granatum 15x, Ipecac 15x, Lachesis 15x, Lycopodium 15x, Mercurius 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 mar 15x, Thymolum 15x, Zingiber 15x.
OTC - PURPOSE SECTION
Formulated for symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.
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.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
QUESTIONS SECTION
newtonlabs.net – Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
PACKAGE LABEL
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2593-1 | Para-Si | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2593 | 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.] | 2 | Current NDC, 1 package rows | 20241127_27d41602-9dcb-eaa8-e063-6394a90a7cfa.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
- TEUCRIUM MARUM
- ARTEMISIA VULGARIS ROOT
- DRYOPTERIS FILIX-MAS ROOT
- JUGLANS REGIA LEAF
- SPIGELIA ANTHELMIA
- THYMOL
- ALCOHOL
- GARLIC
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- BAPTISIA TINCTORIA ROOT
- ARTEMISIA CINA PRE-FLOWERING TOP
- COPPER
- PUNICA GRANATUM ROOT BARK
- IPECAC
- LACHESIS MUTA VENOM
- LYCOPODIUM CLAVATUM SPORE
- MERCURY
- ARTEMISIA ABROTANUM FLOWERING TOP
- NAPHTHALENE
- SODIUM CHLORIDE
- SODIUM CATION
- STRYCHNOS NUX-VOMICA SEED
- ANEMONE PULSATILLA
- KRAMERIA LAPPACEA ROOT
- RUTA GRAVEOLENS FLOWERING TOP
- SCHOENOCAULON OFFICINALE SEED
- SANTONIN
- HORSE CHESTNUT
- WATER
- GINGER
- SILICON DIOXIDE
- TURPENTINE OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2593 | 55714-2593-1 |
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. | 27d41602-9dcb-eaa8-e063-6394a90a7cfa | 2024-11-26 | Warnings | 55714-2593-1 55714-2593 55714259301 27d41614-3a78-e814-e063-6394a90a94bc 27d41602-9dcb-eaa8-e063-6394a90a7cfa |
