Label: KIDS COUGH AND COLD RELIEF PLUS ECHINACEA, NIGHTTIME- atropa belladonna, matricaria recutita, copper, drosera rotundifolia flowering top, echinacea pallida, ferrosoferric phosphate, polygala senega root 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 January 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Belladonna* 6X                        

  • Purpose

    sore throat, nighttime cough, mucus

  • Active Ingredient

    Chamomilla (chamomile) 8X

  • Purpose

    mucus, dry cough, restlessness

  • Active Ingredient

    Cuprum metallicum (copper) 12X

  • Purpose

    hoarseness, mucus, dry cough

  • Active Ingredient

    Drosera (sundew) 4X                  

  • Purpose

    nighttime spasmodic/hacking/tickling cough

  • Active Ingredient

    Echinacea (pale purple coneflower) 6X      

  • Purpose

    immune stimulant

  • Active Ingredient

    Ferrum phosphoricum (iron phosphate) 12X

  • Purpose

    hoarseness, mucus, tickling cough

  • Active Ingredient

    Senega officinalis (mountain flax) 6X            

  • Purpose

    nasal congestion, mucus, dry/hacking/tickling cough

  • Active Ingredient

    Zincum metallicum (zinc) 12X      

  • Purpose

    Roughness/dryness/soreness in throat, tickling cough

  • Uses* 

    According to homeopathic principles, the active ingredients in this product provide immunity support and 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
    • there is a fever of 102°F or greater
  • 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, Natural 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®
    NIGHTTIME

    Kids Cough &
    Cold Relief
    Plus ECHINACEA
    for IMMUNITY SUPPORT
    COUGH SYRUP
    118 ml / 4 fl oz

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

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

  • INGREDIENTS AND APPEARANCE
    KIDS COUGH AND COLD RELIEF PLUS ECHINACEA, NIGHTTIME 
    atropa belladonna, matricaria recutita, copper, drosera rotundifolia flowering top, echinacea pallida, ferrosoferric phosphate, polygala senega root and zinc syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-265
    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
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA8 [hp_X]  in 1 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER12 [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
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 1 mL
    POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF) POLYGALA SENEGA ROOT6 [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:59262-265-251 in 1 BOX02/01/2016
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/01/2016
    Labeler - Similasan Corporation (111566530)
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