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| Product NDC Code | 55714-2594 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Para-si |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Dosage Form | PELLET | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler Name | Newton Laboratories, Inc. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS & USAGE SECTION Formulated for symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE SECTION Formulated for symptoms such as bloating, fatigue, itching, nausea, teeth grinding, increased appetite, cramping and sluggish elimination.
Spl product data elements
Usually a list of ingredients in a drug product.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 SUCROSE JUGLANS REGIA LEAF JUGLANS REGIA LEAF SPIGELIA ANTHELMIA SPIGELIA ANTHELMIA THYMOL THYMOL GARLIC GARLIC ARSENIC TRIOXIDE ARSENIC CATION (3+) BAPTISIA TINCTORIA ROOT BAPTISIA TINCTORIA ROOT ARTEMISIA CINA PRE-FLOWERING TOP ARTEMISIA CINA PRE-FLOWERING TOP COPPER COPPER DRYOPTERIS FILIX-MAS ROOT DRYOPTERIS FILIX-MAS ROOT PUNICA GRANATUM ROOT BARK PUNICA GRANATUM ROOT BARK MERCURY MERCURY IPECAC IPECAC LACHESIS MUTA VENOM LACHESIS MUTA VENOM LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE ARTEMISIA ABROTANUM FLOWERING TOP ARTEMISIA ABROTANUM FLOWERING TOP ANEMONE PULSATILLA ANEMONE PULSATILLA NAPHTHALENE NAPHTHALENE SODIUM CHLORIDE SODIUM CATION STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED KRAMERIA LAPPACEA ROOT KRAMERIA LAPPACEA ROOT RUTA GRAVEOLENS FLOWERING TOP RUTA GRAVEOLENS FLOWERING TOP SCHOENOCAULON OFFICINALE SEED SCHOENOCAULON OFFICINALE SEED SANTONIN SANTONIN HORSE CHESTNUT HORSE CHESTNUT SILICON DIOXIDE SILICON DIOXIDE TURPENTINE OIL TURPENTINE OIL GINGER GINGER TEUCRIUM MARUM TEUCRIUM MARUM ARTEMISIA VULGARIS ROOT ARTEMISIA VULGARIS ROOT
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL package label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS SECTION newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
Pregnancy or breast feeding
Pregnancy or Breast feedingOTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding , ask a doctor before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API