Label: WELLNESS DEFENSE (echinacea (angustifolia), allium cepa, bryonia- alba, gelsemium sempervirens, sanguinaria canadensis, eupatorium perfoliatum, kali bichromicum, phosphorus, aconitum napellus, influenzinum 2019-2020 tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 13, 2020

If you are a consumer or patient please visit this version.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • INACTIVE INGREDIENTS:

    Echinacea Angustifolia Root Extract, Lactose, Magnesium Stearate, Maltodextrin

  • QUESTIONS:

    Source Naturals, Inc.
    P.O. Box 2118
    Santa Cruz, Ca. USA 95062
    www.sourcenaturals.com

  • 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

  • INGREDIENTS AND APPEARANCE
    WELLNESS DEFENSE 
    echinacea (angustifolia), allium cepa, bryonia (alba), gelsemium sempervirens, sanguinaria canadensis, eupatorium perfoliatum, kali bichromicum, phosphorus, aconitum napellus, influenzinum 2019-2020 tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64471-165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION4 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT4 [hp_X]
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [hp_X]
    INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: XW4JB03TI5) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:92XE6GHC89) INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)12 [hp_X]
    INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 3NZW5ND3D6) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K329YCD1N9) INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)12 [hp_X]
    INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8V4458342X) (INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:OES3CXI7E9) INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED)12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64471-165-482 in 1 CARTON02/13/2020
    124 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/13/2020
    Labeler - Source Naturals, Inc. (969024228)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(64471-165) , api manufacture(64471-165) , label(64471-165) , pack(64471-165)