Label: REAL RELIEF NATURAL WELLNESS CALMING SYRUP (asafoetida, strychnos ignatii seed (ignatia amara), valeriana officinalis whole (valeriana officinalis), oat bran (avena sativa), silver nitrate (argentum nitricum), hyoscyamus niger, paeonia officinalis root (paeonia officinalis), datura stramonium, anamirta cocculus whole- cocculus indicus liquid

  • NDC Code(s): 71971-9042-5
  • Packager: Homeolab International (Canada) 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, 2022

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

  • Active Ingredients

    ASAFOETIDA (ASAFETIDA) 8 [hp-X]

    IGNATIA AMARA (IGNATUS BEAN)                        8 [hp-X]

    VALERIANA OFFICINALIS (VALERIAN)                8 [hp-X]

    AVENA SATIVA (OAT)                                                 8 [hp-X]

    ARGENTUM NITRICUM (SILVER NITRATE)          8 [hp-X]

    HYOSCYAMUS NIGER (HENBANE)                        8 [hp-X]

    PAEONIA OFFICINALIS (PEONY)                             8 [hp-X]

    STRAMONIUM (THORN APPLE)                               8 [hp-X]

    ANCOCCULUS INDICUS (INDIAN BERRY)             8 [hp-X]

    The letters 'HPUS' indicate that the compo nents in this pro duct are o fficially mo no g raphed in the Ho mo eo pathic Pharmaco po eia o f the United States.

  • Purpose

    ASAFOETIDA                                  Restlessness and Anxiety

    IGNATIA AMARA                            Nervousness

    VALERIANA OFFICINALIS                Agitation

    AVENA SATIVA                              Sleeplessness

    ARGENTUM NITRICUM                   Nervousness

    ARGENTUM NITRICUM                   Nervousness

    HYOSCYAMUS NIGER                    Anguish and fear

    PAEONIA OFFICINALIS                 Apprehension, anxiety and irritability

    STRAMONIUM                             Nightmares and nervousness

    COCCULUS INDICUS                    Lack of concentration

  • Uses

    This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of*: restlessness, nervousness, irritability, agitation, sleeplessness, lessen nightmares.

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

  • Warnings

    Stop use and ask a doctor if symptoms worsen:

    If you are pregnant or breast feeding, ask a health professional before.

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

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Do not exceed recommended dosage

    • Repeat every 6 hours and reduce with improvement or as directed by a health professional.
    Age………………………………………………………….................Dose
    Adults and Children 12 + years. ............................................10 ml or 2 teaspoon (tsp)
    Children 6 to 11 years of age. ...............................................5 ml or 1 teaspoon (tsp)
    Children 2 to 5 years of age. .................................................2.5 ml or ½ teaspoon (tsp)

  • Other information

    Store at room temperature.• Do not use if seal is broken or missing

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

  • Inactive ingredients

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

  • Product label

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  • INGREDIENTS AND APPEARANCE
    REAL RELIEF NATURAL WELLNESS CALMING SYRUP 
    asafoetida, strychnos ignatii seed (ignatia amara), valeriana officinalis whole (valeriana officinalis), oat bran (avena sativa), silver nitrate (argentum nitricum), hyoscyamus niger, paeonia officinalis root (paeonia officinalis), datura stramonium, anamirta cocculus whole (cocculus indicus) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71971-9042
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) FERULA ASSA-FOETIDA RESIN8 [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)  
    CARAMEL (UNII: T9D99G2B1R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71971-9042-51 in 1 CARTON09/01/2022
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2022
    Labeler - Homeolab International (Canada) inc (203639455)