Label: KIDS RELIEF- asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus liquid

  • NDC Code(s): 63388-910-44, 63388-910-45, 63388-910-49
  • Packager: Laboratoire Atlas Inc
  • 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 November 3, 2023

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

  • ACTIVE INGREDIENT

    Active Ingredients HPUS:

    Asafo etida (Asafetida) 8 [HP_ X] in 100 mL.

    Ignatia amara (Ig natius bean) 8 [ HP_X] in 100 mL.

    Valeriana officinalis (Valerian) 8 [HP_ X] in a 100 mL.

    Avena sativa (Oats) 8 [HP_X] in a 100 mL.

    Argentum nitricum (Silver nitrate) 8 [HP_X] in a 100 mL.

    Hyoscyamus niger (Henbane) 8 [HP_ X] in a 100 mL.

    Paeonia officinalis (Peony) 8 [ HP_ X] in a 100 ml

    Stramonium (Thorn apple) 8 [HP_ X] in a 100 mL.

    Cocculus indicus (Indian berry) 8

  • PURPOSE

    Purpose of the Drug:

    [e.g. sunscreen, analgesic, etc.] Purpose

    Restlessness and anxiety

    Nervousness. Agitation

    Sleeplessness Anguish and fear

    Apprehension, anxiety and irritability

    Nightmares and nervousness

    Lack of concentration

    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 or evalauted by the Food and Drug Administration. They are based on traditional homeopathic practice not

    medical evidence.

    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

  • INDICATIONS & USAGE

    •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

    Warnings

    Stop use and ask a doctor ifsymptoms worsen. 

  • DOSAGE & ADMINISTRATION

    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:

    5ml or 1 teaspoon, every 6 hours or 4 times a day.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental

    overdose, contact a medical professional or a poison

    control center immediately. 

  • STORAGE AND HANDLING

    Other information

    •Store at room temperature

    Do not useif seal is broken or missing

  • INACTIVE INGREDIENT

    Inactive ingredients

    Purified water, sorbitol, grape and rapsberry flavor,

    sodium benzoate, potassium sorbate, citric acid.

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    KIDS RELIEF 
    asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63388-910
    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
    VALERIANA OFFICINALIS WHOLE (UNII: FP6O7F1X9R) (VALERIANA OFFICINALIS WHOLE - UNII:FP6O7F1X9R) VALERIANA OFFICINALIS WHOLE8 [hp_X]  in 100 mL
    OAT BRAN (UNII: KQX236OK4U) (OAT BRAN - UNII:KQX236OK4U) OAT BRAN8 [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 WHOLE (UNII: 8O4P2U3QO2) (ANAMIRTA COCCULUS WHOLE - UNII:8O4P2U3QO2) ANAMIRTA COCCULUS WHOLE8 [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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63388-910-491 in 1 CARTON03/03/2018
    1250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63388-910-451 in 1 CARTON03/03/2018
    2100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:63388-910-4430 mL in 1 BOTTLE; Type 0: Not a Combination Product03/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/2018
    Labeler - Laboratoire Atlas Inc (247880834)