Label: KIDS COLD AND MUCUS RELIEF EXPECTORANT- antimony pentasulfide and potassium iodide and polygala senega root 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 2, 2013

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  • Active Ingredient

    Antimonium sulphuratum aureum 12X

  • Purpose

    loosens mucus, moist cough, chest congestion

  • Active Ingredient

    Kali iodatum 12X

  • Purpose

    cold, fever, sneezing, runny nose, head congestion

  • Active Ingredient

    Senega offcinalis 8X

  • Purpose

    expectorant, dry/hacking cough

  • Uses:

    Temporarily relieves symptoms associated with the common cold, such as: mucus congestion, cough, fever, chest and head congestion.

  • 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:

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

    For children age 2 and over:

    AGEDOSEFREQUENCY
    2-122.5 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 spoon
  • 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 59262-257-25
    Similasan
    Kids Cold & Mucus Relief
    EXPECTORANT SYRUP/
    JARABE EXPECTORANTE
    118 ml / 4 fl oz

    NDC 59262-257-25 Similasan Kids Cold & Mucus Relief EXPECTORANT SYRUP/ JARABE EXPECTORANTE 118 ml / 4 fl oz
  • INGREDIENTS AND APPEARANCE
    KIDS COLD AND MUCUS RELIEF EXPECTORANT 
    antimony pentasulfide and potassium iodide and polygala senega root syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-257
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANTIMONY PENTASULFIDE (UNII: 1433F1I86N) (ANTIMONY PENTASULFIDE - UNII:1433F1I86N) ANTIMONY PENTASULFIDE12 [hp_X]  in 118 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION12 [hp_X]  in 118 mL
    POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF) POLYGALA SENEGA ROOT8 [hp_X]  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-257-25118 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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