Label: KIDS COUGH AND FEVER RELIEF- atropa belladonna and drosera rotundifolia and prunus laurocerasus leaf and rumex crispus root and polygala senega root and verbascum thapsus 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 July 8, 2013

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  • Active Ingredient

    Belladonna* 6X
    * containing 0.0000000016% alkaloids conculated as hyoscyamine

  • Purpose

    fever

  • Active Ingredient

    Drosera 3X

  • Purpose

    nighttime spasmodic, hacking, tickling cough

  • Active Ingredient

    Laurocerasus 4X

  • Purpose

    fever, hacking, dry cough

  • Active Ingredient

    Rumex crispus 4X

  • Purpose

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

  • Active Ingredient

    Senega officinalis 6X

  • Purpose

    nasal congestion, dry/tickling cough

  • Active Ingredient

    Verbascum thapsus 6X

  • Purpose

    hoarse throat, spasmodic cough at night

  • Uses:

    Temporarily relieves symptoms of dry/tickling cough, fever, and nasal congestion due to throat and bronchial irritation occurring with a cold.

  • Warnings

    • Initial exacerbation of symptoms may occur.
    • Do not exceed recommended dosage.
    • Not intended for children under 2.
    • A persistent cough may be a sign of a serious condition.

    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:

    • if symptoms worsen or persist for more than 72 hours
  • Directions:

    For children age 2 and over:

     AGE     DOSE   FREQUENCY
      2-12  2.5 ml

     3 to 6 times daily
    (every 4 hours)
      12+  5 ml  3 to 6 times daily
    (every 4 hours)
    • Replace cap tightly after every use

    Or use as directed by a licensed health care professional.

    dosing scoop
  • Other Information:

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients:

    Purified water, Sorbitol, Sodium chloride, Potassium sorbate, Citric acid

  • Questions?

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

  • Principal Display Panel

    NDC 59262-259-25
    Similasan
    Kids Cough & Fever Relief
    Cough & Fever Syrup
    118 ml / 4fl oz

    NDC 59262-259-25 Similasan Kids Cough & Fever Relief Cough & Fever Syrup 118 ml / 4fl oz

  • INGREDIENTS AND APPEARANCE
    KIDS COUGH AND FEVER RELIEF 
    atropa belladonna and drosera rotundifolia and prunus laurocerasus leaf and rumex crispus root and polygala senega root and verbascum thapsus syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-259
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 118 mL
    DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA3 [hp_X]  in 118 mL
    PRUNUS LAUROCERASUS LEAF (UNII: F26P2D4757) (PRUNUS LAUROCERASUS LEAF - UNII:F26P2D4757) PRUNUS LAUROCERASUS LEAF4 [hp_X]  in 118 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT4 [hp_X]  in 118 mL
    POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF) POLYGALA SENEGA ROOT6 [hp_X]  in 118 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS6 [hp_X]  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-259-25118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC07/02/2013
    Labeler - Similasan Corporation (111566530)
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