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| Product NDC Code | 55714-4859 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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], Inhibit Ovum Fertilization [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], 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 | LIQUID | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 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.
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 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. 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: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%
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, Lachesis, Lycopodium, Merc viv, Naphthalinum, Nat mur Nux vom, Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth, Terebinthina, Teucrium mar, Thymolum, Zingiber WATER ALCOHOL ARTEMISIA ABROTANUM FLOWERING TOP ARTEMISIA ABROTANUM FLOWERING TOP HORSE CHESTNUT HORSE CHESTNUT GARLIC GARLIC ARSENIC TRIOXIDE ARSENIC CATION (3+) ARTEMISIA VULGARIS ROOT ARTEMISIA VULGARIS ROOT 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 IPECAC IPECAC LACHESIS MUTA VENOM LACHESIS MUTA VENOM LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE MERCURY MERCURY NAPHTHALENE NAPHTHALENE SODIUM CHLORIDE CHLORIDE ION STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED ANEMONE PULSATILLA ANEMONE PULSATILLA KRAMERIA LAPPACEA ROOT KRAMERIA LAPPACEA ROOT RUTA GRAVEOLENS FLOWERING TOP RUTA GRAVEOLENS FLOWERING TOP SCHOENOCAULON OFFICINALE SEED SCHOENOCAULON OFFICINALE SEED SANTONIN SANTONIN SILICON DIOXIDE SILICON DIOXIDE SPIGELIA ANTHELMIA SPIGELIA ANTHELMIA GINGER GINGER TURPENTINE OIL TURPENTINE OIL TEUCRIUM MARUM TEUCRIUM MARUM THYMOL THYMOL JUGLANS REGIA LEAF JUGLANS REGIA LEAF
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