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WITH CALMING EFFECT KIDS RELIEF (HOMEOLAB USA INC)

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SYRUP 100 mL in 1 BOTTLE (60512-9164-5) Label Information

Complete WITH CALMING EFFECT KIDS RELIEF Information

  • 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. ï»¿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 Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9164
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA 8 [hp_X]  in 100 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 8 [hp_X]  in 100 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 8 [hp_X]  in 100 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 8 [hp_X]  in 100 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 8 [hp_X]  in 100 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 8 [hp_X]  in 100 mL
    PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT 8 [hp_X]  in 100 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 8 [hp_X]  in 100 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 8 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE, RASPBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60512-9164-5 100 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 05/07/2013
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    Name Address ID/FEI Business Operations
    HOMEOLAB USA INC 202032533 manufacture(60512-9164)