Label: 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
- NDC Code(s): 55714-4859-1
- 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
- DOSAGE & ADMINISTRATION SECTION
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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
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4859 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0) ARTEMISIA ABROTANUM FLOWERING TOP 20 [hp_X] in 1 mL HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 20 [hp_X] in 1 mL GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC 20 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 20 [hp_X] in 1 mL ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) (ARTEMISIA VULGARIS ROOT - UNII:32MP823R8S) ARTEMISIA VULGARIS ROOT 20 [hp_X] in 1 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 20 [hp_X] in 1 mL ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 20 [hp_X] in 1 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 20 [hp_X] in 1 mL DRYOPTERIS FILIX-MAS ROOT (UNII: C0ZK0RRF5X) (DRYOPTERIS FILIX-MAS ROOT - UNII:C0ZK0RRF5X) DRYOPTERIS FILIX-MAS ROOT 20 [hp_X] in 1 mL PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) (PUNICA GRANATUM ROOT BARK - UNII:CLV24I3T1D) PUNICA GRANATUM ROOT BARK 20 [hp_X] in 1 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 20 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 20 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 20 [hp_X] in 1 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 20 [hp_X] in 1 mL NAPHTHALENE (UNII: 2166IN72UN) (NAPHTHALENE - UNII:2166IN72UN) NAPHTHALENE 20 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 20 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 20 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 20 [hp_X] in 1 mL KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT 20 [hp_X] in 1 mL RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 20 [hp_X] in 1 mL SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 20 [hp_X] in 1 mL SANTONIN (UNII: 1VL8J38ERO) (SANTONIN - UNII:1VL8J38ERO) SANTONIN 20 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 20 [hp_X] in 1 mL SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA 20 [hp_X] in 1 mL GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 20 [hp_X] in 1 mL TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F) TURPENTINE OIL 20 [hp_X] in 1 mL TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA) TEUCRIUM MARUM 20 [hp_X] in 1 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 20 [hp_X] in 1 mL JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF 11 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4859-1 30 mL 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(55714-4859)
