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| Product NDC Code | 55714-1723 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Constipation |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], 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 Echinacea 6x, Iris versicolor 6x, Phytolacca decandra 6x, Taraxacum officinale 6x, Abies nigra 15x, Aesculus hippocastanum 15x, Aloe 15x, Alumina 15x, Bryonia 15x, Carbo vegetabilis 15x, Chelidonium majus 15x, Collinsonia canadensis 15x, Graphites 15x, Hydrastis canadensis 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Magnesia muriatica 15x, Mezereum 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rhamnus purshiana 15x, Sanicula 15x, Selenium metallicum 15x, Sepia 15x, Silicea 15x, Tabacum 15x, Veratrum album 15x, Zincum metallicum 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: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) as needed or a directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT SECTION 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 AND USAGE SECTION Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE SECTION Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.
Spl product data elements
Usually a list of ingredients in a drug product.Constipation Echinacea, Iris versicolor, Phytolacca decandra, Taraxacum officinale, Abies nigra, Aesculus hippocastanum, Aloe, Alumina, Bryonia, Carbo vegetabilis, Chelidonium majus, Collinsonia canadensis, Graphite, Hydrastis canadensis 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Magnesia muriatica 15x, Mezereum, Nux vomica, Podophyllum peltatum, Rhamnus purshiana, Sanicula, Selenium metallicum, Sepia, Silicea, Tabacum, Veratrum album, Zincum metallicum ZINC ZINC ECHINACEA, UNSPECIFIED ECHINACEA, UNSPECIFIED COLLINSONIA CANADENSIS ROOT COLLINSONIA CANADENSIS ROOT PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT TARAXACUM OFFICINALE TARAXACUM OFFICINALE PICEA MARIANA RESIN PICEA MARIANA RESIN HORSE CHESTNUT HORSE CHESTNUT ALOE ALOE ALUMINUM OXIDE ALUMINUM OXIDE BRYONIA ALBA ROOT BRYONIA ALBA ROOT ACTIVATED CHARCOAL ACTIVATED CHARCOAL CHELIDONIUM MAJUS CHELIDONIUM MAJUS GOLDENSEAL GOLDENSEAL POTASSIUM CARBONATE CARBONATE ION LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE MAGNESIUM CHLORIDE CHLORIDE ION DAPHNE MEZEREUM BARK DAPHNE MEZEREUM BARK SUCROSE STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PODOPHYLLUM PODOPHYLLUM KRAMERIA LAPPACEA ROOT KRAMERIA LAPPACEA ROOT SANICULA EUROPAEA LEAF SANICULA EUROPAEA LEAF SELENIUM SELENIUM SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE SILICON DIOXIDE SILICON DIOXIDE TOBACCO LEAF TOBACCO LEAF VERATRUM ALBUM ROOT VERATRUM ALBUM ROOT GRAPHITE GRAPHITE IRIS VERSICOLOR ROOT IRIS VERSICOLOR 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 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.
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