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| Product NDC Code | 55714-2578 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Throat care |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC] |
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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, Aconitum nap. 15x, Apis mel. 15x, Arum drac. 15x, Belladonna 15x, Bryonia 15x, Cajuputum 15x, Ferrum phos. 15x, Glycyrrhiza 16x, Kali bic. 15x, Lachesis 15x, Menta pip. 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Nitricum ac. 15x, Nux vom. 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Spongia 15x, Stannum met. 15x, Sticta 15x, Thuja occ. 15x, Ulmus fulv. 16x, Verbascum 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 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 AND USAGE SECTION Formulated for associated symptoms such as dryness, irritation, inflammation, pain and hoarseness.
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE SECTION Formulated for associated symptoms such as dryness, irrtiation, inflammation, pain and hoarseness.
Spl product data elements
Usually a list of ingredients in a drug product.Throat Care Echinacea, Aconitum nap., Apis mel., Arum drac., Belladonna, Bryonia, Cajuputum, Ferrum phos., Glycyrrhiza, Kali bic., Lachesis, Menta pip., Merc. viv., Naja, Nat. carb., Nat sulphuricum, Nitricum ac., Nux vom., Phos., Phytolacca, Pulsatilla, Spongia, Stannum met., Sticta, Thuja occ., Ulmus fulv., Verbascum VERBASCUM THAPSUS VERBASCUM THAPSUS ARISAEMA DRACONTIUM ROOT ARISAEMA DRACONTIUM ROOT ATROPA BELLADONNA ATROPA BELLADONNA MENTHA PIPERITA MENTHA PIPERITA ULMUS RUBRA BARK ULMUS RUBRA BARK PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT ANEMONE PULSATILLA ANEMONE PULSATILLA ECHINACEA, UNSPECIFIED ECHINACEA, UNSPECIFIED ACONITUM NAPELLUS ACONITUM NAPELLUS APIS MELLIFERA APIS MELLIFERA BRYONIA ALBA ROOT BRYONIA ALBA ROOT WATER CAJUPUT OIL CAJUPUT OIL MERCURY MERCURY NAJA NAJA VENOM NAJA NAJA VENOM POTASSIUM DICHROMATE DICHROMATE ION LACHESIS MUTA VENOM LACHESIS MUTA VENOM ALCOHOL SODIUM CARBONATE CARBONATE ION SODIUM SULFATE SODIUM SULFATE ANHYDROUS NITRIC ACID NITRIC ACID STRYCHNOS NUX-VOMICA WHOLE STRYCHNOS NUX-VOMICA WHOLE PHOSPHORUS PHOSPHORUS SPONGIA OFFICINALIS SKELETON, ROASTED SPONGIA OFFICINALIS SKELETON, ROASTED LOBARIA PULMONARIA LOBARIA PULMONARIA THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG FERROSOFERRIC PHOSPHATE FERROSOFERRIC PHOSPHATE GLYCYRRHIZA GLABRA GLYCYRRHIZA GLABRA TIN TIN
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