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| Product NDC Code | 71144-0001 | ||||||||||||||||||||||||||||||||
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| Drug Name | Cold and flu relief |
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| Type | Brand | ||||||||||||||||||||||||||||||||
| Pharm Class | Allergens [CS], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||||||||||||||||
| Dosage Form | SPRAY | ||||||||||||||||||||||||||||||||
| Labeler Name | Attuned Matrix, LLC | ||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS: Baptisia Tinctoria 3X, Calcarea Sulphurica 6X, Allium Cepa 8X, Calcarea Carbonica 8X, Calcarea Phosphorica 8X, Ferrum Phosphoricum 8X, Kali Muriaticum 8X, Kali Sulphuricum 8X, Silicea 8X, Spongia Tosta 8X, Aconitum Napellus 12X, Arsenicum Album 12X, Dulcamara 12X, Euphrasia Officinalis 12X, Eupatorium Perfoliatum 12X, Gelsemium Sempervirens 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.DIRECTIONS: Adults & children over 12 years: Spray twice under the tongue three times per day until symptoms are gone. Children 12 years and under: Consult a Doctor prior to use. Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Ethanol 15%, Glycerin 15%, Purified Water.
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 cold and flu symptoms, such as sinus congestion, achiness, chills, headache, sore throat and fever. For best results use at the first sign of a cold or flu.
Purpose
Information about the drug product’s indications for use.INDICATIONS: For temporary relief of cold and flu symptoms, such as sinus congestion, achiness, chills, headache, sore throat and fever. For best results use at the first sign of a cold or flu.
Spl product data elements
Usually a list of ingredients in a drug product.Cold and Flu Relief Baptisia Tinctoria, Calcarea Sulphurica, Allium Cepa, Calcarea Carbonica, Calcarea Phosphorica, Ferrum Phosphoricum, Kali Muriaticum, Kali Sulphuricum, Silicea, Spongia Tosta, Aconitum Napellus, Arsenicum Album, Dulcamara, Euphrasia Officinalis, Eupatorium Perfoliatum, Gelsemium Sempervirens BAPTISIA TINCTORIA ROOT BAPTISIA TINCTORIA ROOT CALCIUM SULFATE ANHYDROUS CALCIUM CATION ONION ONION OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION FERRUM PHOSPHORICUM FERROSOFERRIC PHOSPHATE POTASSIUM CHLORIDE POTASSIUM CATION POTASSIUM SULFATE SULFATE ION SILICON DIOXIDE SILICON DIOXIDE SPONGIA OFFICINALIS SKELETON, ROASTED SPONGIA OFFICINALIS SKELETON, ROASTED ACONITUM NAPELLUS ACONITUM NAPELLUS ARSENIC TRIOXIDE ARSENIC CATION (3+) SOLANUM DULCAMARA TOP SOLANUM DULCAMARA TOP EUPHRASIA STRICTA EUPHRASIA STRICTA EUPATORIUM PERFOLIATUM FLOWERING TOP EUPATORIUM PERFOLIATUM FLOWERING TOP GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT WATER ALCOHOL GLYCERIN
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: Homeopathic Cold & Flu Relief 2.0 Fluid OZ (60ml) Cold & Flu Relief
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 call 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: Manufactured for Attuned Matrix, LLC 893 Embarcadero Drive #102, El Dorado Hills, CA 95762 (916) 850-5152
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: Do NOT use if you have ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if your symptoms persist, worsen or new symptoms occur. Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away. If pregnant or breast feeding, ask a doctor before using product. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken Store at room temperature and keep out of direct sunlight.
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