FDA.reportPublic FDA data

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

Key Label Information#

Active Ingredients And Purpose

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.

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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.

Directions And Dosage

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.

Other Label Information

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

Label Images#

N053-L01
N053-L01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2593-1Para-Si30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2593PARA-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.]2Current NDC, 1 package rows20241127_27d41602-9dcb-eaa8-e063-6394a90a7cfa.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-259355714-2593-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
TEUCRIUM MARUM10464S0TAAACTIB
ARTEMISIA VULGARIS ROOT32MP823R8SACTIB
DRYOPTERIS FILIX-MAS ROOTC0ZK0RRF5XACTIB
JUGLANS REGIA LEAF85HKB87105ACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
THYMOL3J50XA376EACTIB
ALCOHOL3K9958V90MIACT
GARLICV1V998DC17ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ARTEMISIA CINA PRE-FLOWERING TOP28M1820ACTACTIB
COPPER789U1901C5ACTIB
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
WATER059QF0KO0RIACT
GINGERC5529G5JPQACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
TURPENTINE OILC5H0QJ6V7FACTIB

Complete SPL Sections#

INDICATIONS & USAGE SECTION

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

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

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

OTC - PURPOSE SECTION

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

WARNINGS SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

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

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML