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| Product NDC Code | 43857-0532 | ||||||||||||||||||||||||||||||||||
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| Drug Name | Sinus tonic |
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| Type | Brand | ||||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||||||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||||||||||||||||||||||
| Labeler Name | BioActive Nutritional, Inc. | ||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS: Echinacea (Angustifolia) 1X, Baptisia Tinctoria 3X, Thiaminum Hydrochloricum 4X, Hydrastis Canadensis 5X, Pyridoxinum Hydrochloricum 6X, Spongia Tosta 6X, Apis Mellifica 12X, Ascorbic Acid 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lachesis Mutus 12X, Mercurius Iodatus Ruber 12X, Mercurius Sulphuratus Ruber 12X, Pulsatilla (Pratensis) 12X, Silicea 12X, Sinusitisinum 30X, 60X, 200X, Pantothenic Acid 28C.
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.DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Demineralized Water, 25% Ethanol
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 temporary relief of redness and swelling of the nasal passages with post nasal drip, thick, yellowish discharge from the nose, foul smell; frequent coryza alternating with stoppage.
Purpose
Information about the drug product’s indications for use.INDICATIONS: For temporary relief of redness and swelling of the nasal passages with post nasal drip, thick, yellowish discharge from the nose, foul smell; frequent coryza alternating with stoppage.
Spl product data elements
Usually a list of ingredients in a drug product.Sinus Tonic Echinacea (Angustifolia), Baptisia Tinctoria, Thiaminum Hydrochloricum, Hydrastis Canadensis, Pyridoxinum Hydrochloricum, Spongia Tosta, Apis Mellifica, Ascorbic Acid, Hepar Sulphuris Calcareum, Kali Bichromicum, Lachesis Mutus, Mercurius Iodatus Ruber, Mercurius Sulphuratus Ruber, Pulsatilla (Pratensis), Silicea, Sinusitisinum, Pantothenic Acid ECHINACEA ANGUSTIFOLIA WHOLE ECHINACEA ANGUSTIFOLIA BAPTISIA TINCTORIA ROOT BAPTISIA TINCTORIA ROOT THIAMINE HYDROCHLORIDE THIAMINE ION GOLDENSEAL GOLDENSEAL PYRIDOXINE HYDROCHLORIDE PYRIDOXINE SPONGIA OFFICINALIS SKELETON, ROASTED SPONGIA OFFICINALIS SKELETON, ROASTED APIS MELLIFERA APIS MELLIFERA ASCORBIC ACID ASCORBIC ACID CALCIUM SULFIDE CALCIUM SULFIDE POTASSIUM DICHROMATE DICHROMATE ION LACHESIS MUTA VENOM LACHESIS MUTA VENOM MERCURIC IODIDE MERCURIC IODIDE MERCURIC SULFIDE MERCURIC CATION PULSATILLA PRATENSIS WHOLE PULSATILLA PRATENSIS WHOLE SILICON DIOXIDE SILICON DIOXIDE SINUSITISINUM SINUSITISINUM PANTOTHENIC ACID PANTOTHENIC ACID WATER ALCOHOL
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 DISPLAY: BIOActive Nutritional SINUS TONIC HOMEOPATHIC 2 FL OZ (60 ml) Sinus Tonic
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: In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS: Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 bioactivenutritional.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 pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
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