Label: COLD AND FLU RELIEF pellet

  • NDC Code(s): 71409-304-80
  • Packager: Clineva Management Services, LLC
  • 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 July 6, 2018

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  • Inactive Ingredients


    Sucrose

    Lactose

  • Active ingredients

    Acon. nap 14X, Allium cepa 8X, Arnica m. 8X, Dulcamara 8X, Eupatorium cann. 8X, Gelsemium 18X

  • Directions:

    Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissilve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

  • Warnings:

    Keep out of reach of children.

  • Uses:

    *For the temporary relief of minor fever, chills, runny nose, congestion, body aches adn fatigue due to the common cold or the flu.

  • Warnings

    If symptoms persist or worsen, or if pregnant or nursing, consult a doctor. Keep out of reach of children. Do not use if cap seal is broken or missing.

  • Question, Comments?

    Call 1-844-254-6382

  • INDICATIONS & USAGE

    Uses: For the temporary relief of minor fever, chills, runny nose, congestion, body aches and fatigue due to the common cold or the flu

  • PRINCIPAL DISPLAY PANEL

    Cold and Flu Label.jpg

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU RELIEF 
    cold and flu relief pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71409-304
    Route of AdministrationORAL, SUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLIUM CEPA WHOLE (UNII: 8P2VLG2456) (ALLIUM CEPA WHOLE - UNII:8P2VLG2456) ALLIUM CEPA WHOLE8 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS14 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA8 [hp_X]
    SOLANUM DULCAMARA WHOLE (UNII: G72JA9DHK5) (SOLANUM DULCAMARA WHOLE - UNII:G72JA9DHK5) SOLANUM DULCAMARA WHOLE8 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT18 [hp_X]
    EUPATORIUM CANNABINUM WHOLE (UNII: 1UEC056CS0) (EUPATORIUM CANNABINUM WHOLE - UNII:1UEC056CS0) EUPATORIUM CANNABINUM WHOLE8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71409-304-8080 in 1 VIAL, DISPENSING; Type 0: Not a Combination Product07/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/14/2017
    Labeler - Clineva Management Services, LLC (092689945)
    Registrant - HomeoCare Laboratories Inc. (088248828)
    Establishment
    NameAddressID/FEIBusiness Operations
    HomeoCare Laboratories088248828manufacture(71409-304)
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