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| Product NDC Code | 55714-1529 | ||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Sniffles |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Allergens [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], 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 | 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 napellus 15x, Aralia quinquefolia 15x, Arsenicum album 15x, Bryonia 15x, Euphrasia officinalis 15x, Gaultheria procumbens 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, Hydrastis canadensis 15x, Kali bichromicum 15x, Lycopodium clavatum 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Salvia officinalis 15x, Sticta pulmonaria 15x, Thuja occidentalis 15x, Verbascum thapsus 15x, Sinusitisinum 16x, Influenzinum 30x.
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 drops by mouth (ages 12 and up, give 6 drops) as needed or as directed by a health professional. Sensitive person 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 congestion, runny nose, post-nasal drip, sinus pressure and irritated throat.
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE SECTION Formulated for associated symptoms such as congestion, runny nose, post-nasal drip, sinus pressure and irritated throat.
Spl product data elements
Usually a list of ingredients in a drug product.Sniffles Echinacea, Aconitum napellus, Aralia quinquefolia, Arsenicum album, Bryonia, Euphrasia officinalis, Gaultheria procumbens, Gelsemium sempervirens, Histaminum hydrochloricum, Hydrastis canadensis, Kali bichromicum, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia officinalis, Sticta pulmonaria, Thuja occidentalis, Verbascum thapsus, Sinusitisinum, Influenzinum ECHINACEA, UNSPECIFIED ECHINACEA, UNSPECIFIED STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED AMERICAN GINSENG AMERICAN GINSENG ARSENIC TRIOXIDE ARSENIC CATION (3+) BRYONIA ALBA ROOT BRYONIA ALBA ROOT EUPHRASIA STRICTA EUPHRASIA STRICTA GAULTHERIA PROCUMBENS TOP GAULTHERIA PROCUMBENS TOP GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT HISTAMINE DIHYDROCHLORIDE HISTAMINE GOLDENSEAL GOLDENSEAL POTASSIUM DICHROMATE DICHROMATE ION LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE WATER ANEMONE PULSATILLA ANEMONE PULSATILLA TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SAGE SAGE LOBARIA PULMONARIA LOBARIA PULMONARIA THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG ALCOHOL VERBASCUM THAPSUS VERBASCUM THAPSUS SINUSITISINUM SINUSITISINUM INFLUENZA A VIRUS INFLUENZA A VIRUS INFLUENZA B VIRUS INFLUENZA B VIRUS PHOSPHORUS PHOSPHORUS ACONITUM NAPELLUS ACONITUM NAPELLUS
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.
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