PARA-SI- juglans reg, abrotanum, aesculus hipp, allium sat, arsenicum alb, artemisia, baptisia, cina, cuprum met, filix mas, granatum, ipecac, lacheis, lycopodium, merc viv, naphthalinum, nat mur, nux vom, pulsatilla, ratanhia, ruta, sabadilla, santoninum, silicea, spigelia anth, terebinthina, teucrium mar, thymolum, zingiber pellet

Para-Si by

Drug Labeling and Warnings

Para-Si by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet 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, Merc 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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

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

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

INGREDIENTS AND APPEARANCE

PARA-SI 
juglans reg, abrotanum, aesculus hipp, allium sat, arsenicum alb, artemisia, baptisia, cina, cuprum met, filix mas, granatum, ipecac, lacheis, lycopodium, merc viv, naphthalinum, nat mur, nux vom, pulsatilla, ratanhia, ruta, sabadilla, santoninum, silicea, spigelia anth, terebinthina, teucrium mar, thymolum, zingiber pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-2594
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105)	JUGLANS REGIA LEAF	6 [hp_X]  in 1 g
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	15 [hp_X]  in 1 g
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	15 [hp_X]  in 1 g
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17)	GARLIC	15 [hp_X]  in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X]  in 1 g
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	15 [hp_X]  in 1 g
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT)	ARTEMISIA CINA PRE-FLOWERING TOP	15 [hp_X]  in 1 g
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	15 [hp_X]  in 1 g
DRYOPTERIS FILIX-MAS ROOT (UNII: C0ZK0RRF5X) (DRYOPTERIS FILIX-MAS ROOT - UNII:C0ZK0RRF5X)	DRYOPTERIS FILIX-MAS ROOT	15 [hp_X]  in 1 g
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) (PUNICA GRANATUM ROOT BARK - UNII:CLV24I3T1D)	PUNICA GRANATUM ROOT BARK	15 [hp_X]  in 1 g
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	15 [hp_X]  in 1 g
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	15 [hp_X]  in 1 g
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	15 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [hp_X]  in 1 g
ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0)	ARTEMISIA ABROTANUM FLOWERING TOP	15 [hp_X]  in 1 g
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	15 [hp_X]  in 1 g
NAPHTHALENE (UNII: 2166IN72UN) (NAPHTHALENE - UNII:2166IN72UN)	NAPHTHALENE	15 [hp_X]  in 1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	15 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X]  in 1 g
KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z)	KRAMERIA LAPPACEA ROOT	15 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	15 [hp_X]  in 1 g
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	15 [hp_X]  in 1 g
SANTONIN (UNII: 1VL8J38ERO) (SANTONIN - UNII:1VL8J38ERO)	SANTONIN	15 [hp_X]  in 1 g
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	15 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 [hp_X]  in 1 g
TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F)	TURPENTINE OIL	15 [hp_X]  in 1 g
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	15 [hp_X]  in 1 g
TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA)	TEUCRIUM MARUM	15 [hp_X]  in 1 g
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) (ARTEMISIA VULGARIS ROOT - UNII:32MP823R8S)	ARTEMISIA VULGARIS ROOT	15 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-2594-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/26/2024

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-2594)