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| Product NDC Code | 44911-0515 | ||||||||||||||||||||
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| Drug Name | Sinutone |
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| Type | Brand | ||||||||||||||||||||
| Pharm Class | Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||||||||
| Labeler Name | Energique, Inc. | ||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS: (in each drop): 11.10% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Hydrastis Canadensis 6X, Kali Bichromicum 12X, Nux Moschata 12X, Pulsatilla (Pratensis) 12X, Sepia 12X, Solidago Virgaurea 12X; 0.10% of Echinacea (Angustifolia) 3X.
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: Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. 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, 20% 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: May temporarily relieve allergic rhinitis with runny nose, nasal mucus with yellow green discharge, pain and swelling of sinus cavities, and postnasal drip.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Purpose
Information about the drug product’s indications for use.INDICATIONS: May temporarily relieve allergic rhinitis with runny nose, nasal mucus with yellow green discharge, pain and swelling of sinus cavities, and postnasal drip.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Spl product data elements
Usually a list of ingredients in a drug product.Sinutone Echinacea (Angustifolia), Hydrastis Canadensis, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Kali Bichromicum, Nux Moschata, Pulsatilla (Pratensis), Sepia, Solidago Virgaurea ECHINACEA ANGUSTIFOLIA WHOLE ECHINACEA ANGUSTIFOLIA GOLDENSEAL GOLDENSEAL ONION ONION AMBROSIA ARTEMISIIFOLIA WHOLE AMBROSIA ARTEMISIIFOLIA ARSENIC TRIOXIDE ARSENIC CATION (3+) POTASSIUM DICHROMATE DICHROMATE ION NUTMEG NUTMEG PULSATILLA PRATENSIS WHOLE PULSATILLA PRATENSIS WHOLE SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE SOLIDAGO VIRGAUREA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP 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: ENERGIQUE SINCE 1987 HOMEOPATHIC REMEDY SINUTONE 1 fl. oz. (30 ml) Sinutone
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: 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: Dist. by Energique, Inc. 201 Apple Blvd. Woodbine, IA 51579 800-869-8078
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 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