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Product NDC Code | 64471-165 | ||||||||||||||||||||||||
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Drug Name | Wellness defense |
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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 | ORAL | ||||||||||||||||||||||||
Dosage Form | TABLET | ||||||||||||||||||||||||
Labeler Name | Source Naturals, Inc. | ||||||||||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS: Echinacea (Angustifolia) 3X, Allium Cepa 4X, Bryonia (Alba) 4X, Gelsemium Sempervirens 4X, Sanguinaria Canadensis 4X, Eupatorium Perfoliatum 6X, Kali Bichromicum 6X, Phosphorus 6X, Aconitum Napellus 12X, Influenzinum 2019-2020 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: Chew 1 tablet slightly and allow to dissolve in the mouth. Adults 17 years and up: take 1 every 2 to 4 hours until symptoms improve, then take as needed. For optimal results, take 3-6 doses per day. Consult a doctor for use in children under 17 years of age. For Best Results: Keep mouth free of food and strong tastes (such as toothpaste, mouthwash and tobacco) for 15 minutes before and after taking this medicine. These substances may interfere with sublingual absorption.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Echinacea Angustifolia Root Extract, Lactose, Magnesium Stearate, Maltodextrin
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 runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of immune imbalance.
Purpose
Information about the drug product’s indications for use.INDICATIONS: For the temporary relief of runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of immune imbalance.
Spl product data elements
Usually a list of ingredients in a drug product.Wellness Defense Echinacea (Angustifolia), Allium Cepa, Bryonia (Alba), Gelsemium Sempervirens, Sanguinaria Canadensis, Eupatorium Perfoliatum, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum 2019-2020 ECHINACEA ANGUSTIFOLIA WHOLE ECHINACEA ANGUSTIFOLIA ONION ONION BRYONIA ALBA ROOT BRYONIA ALBA ROOT GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT EUPATORIUM PERFOLIATUM FLOWERING TOP EUPATORIUM PERFOLIATUM FLOWERING TOP POTASSIUM DICHROMATE DICHROMATE ION PHOSPHORUS PHOSPHORUS ACONITUM NAPELLUS WHOLE ACONITUM NAPELLUS INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) ECHINACEA ANGUSTIFOLIA ROOT LACTOSE MONOHYDRATE MAGNESIUM STEARATE MALTODEXTRIN H
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: SOURCE NATURALS with homeopathic echinacea BIO ALIGN Wellness Defense Relieves Symptoms: Fever • Sore Throat • Sneezing • Body Aches • Chest Congestion 48 HOMEOPATHIC TABLETS Wellness Defense Wellness Defense
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 this and all medicines out of the 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: Source Naturals, Inc. P.O. Box 2118 Santa Cruz, Ca. USA 95062 www.sourcenaturals.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: In case of overdose, get medical help or contact a Poison Control Center right away. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 17 years of age unless directed by a physician. A persistent cough or high fever may be the sign of a serious health condition. If fever persists for more than 3 days, consult a physician. If cough persists for more than one week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a physician Do not take this product for consistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician. As with any medicine, if you are pregnant, may become pregnant, or breastfeeding, seek the advice of a health care professional before using this product. Keep this and all medicines out of the reach of children. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Tamper Evident: Do not use if foil blister backing is broken. Foil backing is printed with product name and lot number. STORE IN A COOL, DRY PLACE. Contains milk.
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