Label: 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

  • NDC Code(s): 55714-2594-1
  • Packager: Newton Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated November 26, 2024

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  • 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

    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2594
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF6 [hp_X]  in 1 g
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA15 [hp_X]  in 1 g
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL15 [hp_X]  in 1 g
    GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC15 [hp_X]  in 1 g
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 g
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT15 [hp_X]  in 1 g
    ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP15 [hp_X]  in 1 g
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER15 [hp_X]  in 1 g
    DRYOPTERIS FILIX-MAS ROOT (UNII: C0ZK0RRF5X) (DRYOPTERIS FILIX-MAS ROOT - UNII:C0ZK0RRF5X) DRYOPTERIS FILIX-MAS ROOT15 [hp_X]  in 1 g
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) (PUNICA GRANATUM ROOT BARK - UNII:CLV24I3T1D) PUNICA GRANATUM ROOT BARK15 [hp_X]  in 1 g
    MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY15 [hp_X]  in 1 g
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC15 [hp_X]  in 1 g
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 g
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 g
    ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0) ARTEMISIA ABROTANUM FLOWERING TOP15 [hp_X]  in 1 g
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 g
    NAPHTHALENE (UNII: 2166IN72UN) (NAPHTHALENE - UNII:2166IN72UN) NAPHTHALENE15 [hp_X]  in 1 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE15 [hp_X]  in 1 g
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED15 [hp_X]  in 1 g
    KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT15 [hp_X]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP15 [hp_X]  in 1 g
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED15 [hp_X]  in 1 g
    SANTONIN (UNII: 1VL8J38ERO) (SANTONIN - UNII:1VL8J38ERO) SANTONIN15 [hp_X]  in 1 g
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT15 [hp_X]  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15 [hp_X]  in 1 g
    TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F) TURPENTINE OIL15 [hp_X]  in 1 g
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER15 [hp_X]  in 1 g
    TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA) TEUCRIUM MARUM15 [hp_X]  in 1 g
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) (ARTEMISIA VULGARIS ROOT - UNII:32MP823R8S) ARTEMISIA VULGARIS ROOT15 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2594-128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/26/2024
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-2594)
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