Label: WITH CALMING EFFECT KIDS RELIEF- asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, 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 April 2, 2014

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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

    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

    Anguish and fear

    Apprehension, anxiety and irritability

    Nightmares and nervousness

    Lack of concentration

  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

  • Uses

    This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of:

    • restlessness

    • nervousness

    • irritability

    • agitation

    • sleeplessness

    • lessens nightmares

  • Warnings


    Stop use and ask a doctor if symptoms worsen.

    Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

  • Directions

    Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

    Children 6 months to 2 years old: 2.5 ml or 1/2 teaspoon every 6 hours or 4 times a day.

    Children 2 to 12 years old: 5 ml or 1 teaspoon every 6 hours or 4 times a day.

  • Other information

    Store at room temperature.

    Do not use if seal is broken or missing.

  • Inactive Ingredients

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

  • CARTON

    image of carton

  • LABEL

    image of label

  • INGREDIENTS AND APPEARANCE
    WITH CALMING EFFECT KIDS RELIEF 
    asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9164
    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
    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:60512-9164-5100 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/07/2013
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9164)
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