Label: KIDS COLD- allium cepa 30c, kali bichromium 30c, kali sulphuricum 30c, nux vomica 30c, natrum muriaticum 30c, pulsatilla 30c, silicea 30c lozenge

  • 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 May 3, 2014

If you are a consumer or patient please visit this version.

  • INACTIVE INGREDIENT

    Non-Active Ingredients

    Sorbitol, Citric Acid,

    Flavours, Bix orellana

    (annato) seed powder,

    tumeric, cabbage

    Ingredients are derived

    from natural sources

  • ACTIVE INGREDIENT

    Each Lozenge contains:

    Allium Cepa 30C,

    Kali Bichromium 30C,

    Kali Sulphericum 30C,

    Nux Vomica 30C,

    Natrum Muriaticum 30C,

    Pulsatilla 30C,

    Silicea 30C

  • PURPOSE

    Indications

    For natural, temporary relief of

    cold and influenza symptoms  (headache,

    stuffy nose, nasal discharge, watery eyes,

    sneezing, aching cough, chills)

  • WARNINGS

    Warning: If symptoms persist or worsen suddenly, consult your health-care

    specialist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all other medication out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    For best results, begin taking one

    KidsCold at the first sign of a cough, cold or sore

    throat. Suck KidsCold and avoid chewing as it reduces

    absorption of active ingredients. Recommended dosage

    3 per day. Use only when symptoms exist. Not to be used

    in children under 2 years of age without

    medical advice.

  • INDICATIONS & USAGE

    Indications

    For natural temporary relief of

    cold and influenze symptoms (headache,

    stuffy nose, nasal discharge, watery eyes

    sneezing aching cough, chills)

    Non-drowsy.

  • STORAGE AND HANDLING

    STORE BELOW 30C

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    KIDS COLD  
    allium cepa 30c, kali bichromium 30c, kali sulphuricum 30c, nux vomica 30c, natrum muriaticum 30c, pulsatilla 30c, silicea 30c lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64997-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION30 [hp_X]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE30 [hp_X]
    POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG) POTASSIUM SULFATE30 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BIXA ORELLANA SEED (UNII: O87354RZ5A)  
    TURMERIC (UNII: 856YO1Z64F)  
    CABBAGE (UNII: GW0W1Y9I97)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeROUNDSize31mm
    FlavorRASPBERRY (raspberry) Imprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64997-200-0210 in 1 BOX
    1NDC:64997-200-011 in 1 CELLO PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/30/2014
    Labeler - KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES (751652405)
    Establishment
    NameAddressID/FEIBusiness Operations
    KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES751652405manufacture(64997-200)