Label: CALM KIDS RELIEF- asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, tarentula hispana, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus 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 December 14, 2018

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  • ACTIVE INGREDIENTS HPUS

    Asafoetida (Asafetida) 8X

    Ignatia amara (Ignatius bean) 8X

    Valeriana officinalis (Valerian) 8X

    Avena sativa (Oats) 8X

    Argentum nitricum (Silver nitrate) 8X

    Tarentula hispana (Tarantula) 8X

    Hyoscyamus niger (Henbane) 8X

    Paeonia officinalis (Peony) 8X

    Stramonium (Thorn apple) 8X

    Cocculus indicus (Indian berry) 8X

  • PURPOSE

    Restlessness and anxiety.

    Nervousness.

    Agitation.

    Sleeplessness.

    Nervousness.

    Nightmares.

    Anguish and fear.

    Apprehension, anxiety and irritability.

    Nightmares and nervousness.

    Lack of concentration.

  • REFERENCES

    This product is manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS).

  • USES

    This homeopathic medicine helps relieve:

    - restlessness

    - nervousness

    - irritability

    - agitation

    - sleeplessness

    - lessens nightmares.

  • WARNINGS


    Do not use if seal is broken or missing.

    Stop use and ask a doctor if symptoms worsen.

    Keep out of reach of children.

  • DIRECTIONS

    Do not use more than directed.

    Do not take with food.

    Repeat every 4 hours and reduce with improvement or as directed by a healthcare professional.


    Children 6 years of age and older: 1 teaspoon

    Children 2 to 5 years of age: 1/2 teaspoon

    Children under 2 years of age: Ask a doctor.

  • OTHER INFORMATION

    Store at room temperature.

  • INACTIVE INGREDIENTS

    Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.

  • CARTON

    image of carton label

  • LABEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    CALM KIDS RELIEF 
    asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, tarentula hispana, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9064
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA8 [hp_X]  in 100 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED8 [hp_X]  in 100 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN8 [hp_X]  in 100 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP8 [hp_X]  in 100 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE8 [hp_X]  in 100 mL
    LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA8 [hp_X]  in 100 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER8 [hp_X]  in 100 mL
    PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT8 [hp_X]  in 100 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM8 [hp_X]  in 100 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED8 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE, RASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9064-51 in 1 CARTON08/18/2008
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/18/2008
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9064)
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