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| Product NDC Code | 66492-004 | ||||||||||||||
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| Drug Name | Sinus |
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| Type | Brand | ||||||||||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS] |
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| Active Ingredients |
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| Route | NASAL | ||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||
| Labeler Name | Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS: Pulsatilla 2X, Euphorbium 4X, Allium Cepa 6X, Histaminum 6X, Luffa Operculata 6X, Sabadilla 6X, Hepar Sulfur 12X
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: 1 spray in each nostril three to eight times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Demineralized Water, Sodium Chloride, Benzalkonium Chloride.
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: For the temporary relief of acute and chronic rhinitis, sinusitis and hayfever.
Purpose
Information about the drug product’s indications for use.Temporary relief of acute and chronic rhinitis, sinusitis and hayfever.
Spl product data elements
Usually a list of ingredients in a drug product.SINUS Pulsatilla, Euphorbium, Allium Cepa, Histaminum, Luffa Operculata, Sabadilla, Hepar Sulfur. WATER SODIUM CHLORIDE BENZALKONIUM CHLORIDE PULSATILLA VULGARIS PULSATILLA VULGARIS EUPHORBIA RESINIFERA RESIN EUPHORBIA RESINIFERA RESIN ONION ONION HISTAMINE DIHYDROCHLORIDE HISTAMINE LUFFA OPERCULATA FRUIT LUFFA OPERCULATA FRUIT SCHOENOCAULON OFFICINALE SEED SCHOENOCAULON OFFICINALE SEED CALCIUM SULFIDE CALCIUM SULFIDE
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.NDC 66492-004-02 Be Well Homeopathics™ SINUS NASAL SPRAY 30 ml 1oz bottle label Temporary relief of acute and chronic rhinitis, sinusitis and hayfever.
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.Keep out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.TAMPER EVIDENT: There is a safety seal on the neck and cap of the bottle. Do not use this product if the safety seal is broken or missing. Store tightly closed, protect from excessive heat, light and moisture.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Manufactured for: Be Well Homeopathics Inc. Miami, Florida 33178 1-877-438-3042 www.bewellhomeo.com
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: If symptoms persist or worsen, a health professional should be consulted. As with any drug, if you are pregnant or nursing seek the advice of your physician before using the product. KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN. Keep out of reach of children.
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