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| Product NDC Code | 55714-2412 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Constipation |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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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 Echinacea 6x, Iris vers. 6x, Phytolacca 6x, Taraxacum 6x, Abies nig. 15x, Aesculus hipp. 15x, Aloe 15x, Alumina 15x, Bryonia 15x, Carbo veg. 15x, Chelidonium majus 15x, Collinsonia 15x, Graphites 15x, Hydrastis 15x, Kali carb. 15x, Lycopodium 15x, Mag. mur. 15x, Mezereum 15x, Nux vom. 15x, Podoph. pelt. 15x, Rhamnus purshiana 15x, Sanicula 15x, Selenium 15x, Sepia 15x, Silicea 15x, Tabacum 15x, Veratrum alb. 15x, Zinc.met. 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 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
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 associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE SECTION Formulated for associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.
Spl product data elements
Usually a list of ingredients in a drug product.Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia , Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc.met., Echinacea, Iris versicolor, Phytolacca, Taraxacum ALCOHOL 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 COLLINSONIA CANADENSIS ROOT COLLINSONIA CANADENSIS ROOT GRAPHITE GRAPHITE GOLDENSEAL GOLDENSEAL POTASSIUM CARBONATE CARBONATE ION LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE MAGNESIUM CHLORIDE MAGNESIUM CATION DAPHNE MEZEREUM BARK DAPHNE MEZEREUM BARK STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PODOPHYLLUM PODOPHYLLUM FRANGULA PURSHIANA BARK FRANGULA PURSHIANA BARK 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 ZINC ZINC ECHINACEA, UNSPECIFIED ECHINACEA, UNSPECIFIED IRIS VERSICOLOR ROOT IRIS VERSICOLOR ROOT PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT TARAXACUM OFFICINALE TARAXACUM OFFICINALE WATER
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 Laboratoires, Inc. 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 , as 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