Label: KIDS COLD AND MUCUS RELIEF PLUS ECHINACEA- atropa belladonna, drosera rotundifolia flowering top, echinacea pallida, prunus laurocerasus leaf, rumex crispus root, linum catharticum, verbascum thapsus and zinc syrup

  • 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 September 29, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Belladonna* 6X                        

  • Purpose

    sore throat, cough, mucus

  • Active Ingredient

    Drosera (sundew) 4X                  

  • Purpose

    spasmodic/hacking/tickling cough

  • Active Ingredient

    Echinacea (pale purple coneflower) 6X      

  • Purpose

    immune stimulant

  • Active Ingredient

    Laurocerasus (cherry laurel) 4X            

  • Purpose

    hacking, dry cough

  • Active Ingredient

    Rumex crispus (yellow dock) 4X            

  • Purpose

    hoarse throat, nasal congestion, dry cough worse with cold air

  • Active Ingredient

    Senega officinalis (mountain flax) 6X      

  • Purpose

    nasal congestion, mucus dry/hacking/tickling cough

  • Active Ingredient

    Verbascum thapsus (common mullein) 6X      

  • Purpose

    hoarse throat, spasmodic cough at night

  • Active Ingredient

    Zincum metallicum (zinc) 12X      

  • Purpose

    roughness/dryness/soreness in throat, cough

  • Uses:

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

    • Cough
    • Mucus
    • Congestion
  • Warnings:

    • According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).
    • Do not exceed recommended dosage.
    • Not intended for children under 2.
    • A persistent cough may be a sign of a serious condition.
    • Do not use in case of hypersensitivity/allergy to the ingredients

    If pregnant, trying to get pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if

    symptoms worsen or persist for more than 72 hours

  • Directions:

    For children age 2 and over:

    AGEDOSEFREQUENCY
    2-122.5 ml (½ tsp)3 to 6 times daily (every 4 hours)
    12+5 ml (1 tsp)3 to 6 times daily (every 4 hours)
    • Replace cap tightly after every use
    • Or use as directed by a licensed health care professional.
  • Other Information:

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients:

    Citric acid, Grape flavor, Purified water, Sorbitol

    Questions? Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com www.SimilasanUSA.com

    *containing 0.0000000016% alkaloids calculated as hyoscyamine

  • PRINCIPAL DISPLAY PANEL

    Similasan®
    Kids Cold &
    Mucus Relief
    Plus ECHINACEA
    for IMMUNITY SUPPORT
    EXPECTORANT SYRUP
    118 ml / 4 fl oz

    PRINCIPAL DISPLAY PANEL Similasan® Kids Cold & Mucus Relief Plus ECHINACEA for IMMUNITY SUPPORT EXPECTORANT SYRUP 118 ml / 4 fl oz

    PRINCIPAL DISPLAY PANEL Similasan® Kids Cold & Mucus Relief Plus ECHINACEA for IMMUNITY SUPPORT EXPECTORANT SYRUP 118 ml / 4 fl oz

  • INGREDIENTS AND APPEARANCE
    KIDS COLD AND MUCUS RELIEF PLUS ECHINACEA 
    atropa belladonna, drosera rotundifolia flowering top, echinacea pallida, prunus laurocerasus leaf, rumex crispus root, linum catharticum, verbascum thapsus and zinc syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53799-266
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 1 mL
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP4 [hp_X]  in 1 mL
    ECHINACEA PALLIDA (UNII: 904CK3270L) (ECHINACEA PALLIDA - UNII:904CK3270L) ECHINACEA PALLIDA6 [hp_X]  in 1 mL
    PRUNUS LAUROCERASUS LEAF (UNII: F26P2D4757) (PRUNUS LAUROCERASUS LEAF - UNII:F26P2D4757) PRUNUS LAUROCERASUS LEAF4 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT4 [hp_X]  in 1 mL
    LINUM CATHARTICUM (UNII: A9L9GRH405) (LINUM CATHARTICUM - UNII:A9L9GRH405) LINUM CATHARTICUM6 [hp_X]  in 1 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS6 [hp_X]  in 1 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53799-266-251 in 1 BOX02/01/2016
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/01/2016
    Labeler - Similasan AG (481545754)
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