Label: WELLNESS COLD AND FLU (echinacea (angustifolia), allium cepa, bryonia- alba, gelsemium sempervirens, sanguinaria canadensis, eupatorium perfoliatum, kali bichromicum, phosphorus, aconitum napellus, influenzinum 2015-2016, tablet, chewable

  • Category: HUMAN OTC 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 November 1, 2024

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 12, Influenzinum 2015-2016 12X.

  • INDICATIONS:

    For the temporary relief of cold and flu symptoms, runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of symptoms.  Effective at all stages of cold and flu.

  • 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 2 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 is 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.

    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.

  • 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 and children over age 12 take 1 every 2 to 4 hours until symptoms improve, then take as needed.  For optimal results, take 3-6 doses per day.

    Children ages 2 to 12 years, use one half the adult dosage.  

    For children under the age of 2 years, consult your health care professional.

    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 cold and flu symptoms, runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of symptoms. Effective at all stages of cold and flu.

  • INACTIVE INGREDIENTS:

    Lactose, Magnesium Stearate And Echinacea Angustifolia Root Extract.

  • QUESTIONS:

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

  • PACKAGE LABEL DISPLAY:

    SOURCE NATURALS

    with homeopathic                                                 safe & effective

    echinacea                                                             formula

    BIO

     ALIGN

    Wellness

    Cold & Flu

    Relieves Symptoms: Fever • Sore Throat • Sneezing • Body Aches • Chest Congestion

    48 HOMEOPATHIC TABLETS

    Wellness Cold & Flu           front

    Wellness Cold & Flu              back

  • INGREDIENTS AND APPEARANCE
    WELLNESS COLD AND FLU 
    echinacea (angustifolia), allium cepa, bryonia (alba), gelsemium sempervirens, sanguinaria canadensis, eupatorium perfoliatum, kali bichromicum, phosphorus, aconitum napellus, influenzinum 2015-2016, tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64471-164
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE3 [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 WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE12 [hp_X]
    INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: KFL1W6W9JB) (INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:KFL1W6W9JB) INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)12 [hp_X]
    INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 80T3QS071U) (INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:80T3QS071U) INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)12 [hp_X]
    INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: V3EC8AF8MF) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:V3EC8AF8MF) INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)12 [hp_X]
    INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 445486QJCG) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:445486QJCG) INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)12 [hp_X]
    INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 9VVQ21KI5Z) (INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:9VVQ21KI5Z) INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)12 [hp_X]
    INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 3W5C8YUT4D) (INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:3W5C8YUT4D) INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (TABLET) Size10mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64471-164-482 in 1 CARTON11/17/201612/17/2024
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/15/201612/17/2024
    Labeler - Source Naturals, Inc. (969024228)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(64471-164) , api manufacture(64471-164) , label(64471-164) , pack(64471-164)