Label: QUIET CALM- avena sativa, ammonium bromatum, chamomilla, coffea cruda, gelsemium sempervirens, l-tryptophan, phosphoricum acidum, valeriana officinalis liquid

  • 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 January 10, 2023

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  • ACTIVE INGREDIENTS:

    Avena Sativa 1X, Ammonium Bromatum 3X, Chamomilla 6X, Coffea Cruda 6X, Gelsemium Sempervirens 6X, L-Tryptophan 6X, Phosphoricum Acidum 6X, Valeriana Officinalis 30X.

  • INDICATIONS:

    For the temporary relief of symptoms related to sleep dysfunction, mood swings, and nervous anxiety.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact physician or Poison Control Center right away.

    Do not use if seal is broken or missing.

    Store in a cool dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact physician or Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day or as directed by a health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For the temporary relief of symptoms related to sleep dysfunction, mood swings, and nervous anxiety.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Dist. By: Holistic Haven

    Westlake Village, CA 91362

    holistichavenpharmacy.com

    1-866-676-HEAL

  • PACKAGE LABEL DISPLAY:

    Holistic Haven

    Quiet

    Calm

    HOMEOPATHIC

    2 FL OZ (59 ml)

    Quiet Calm

  • INGREDIENTS AND APPEARANCE
    QUIET CALM 
    avena sativa, ammonium bromatum, chamomilla, coffea cruda, gelsemium sempervirens, l-tryptophan, phosphoricum acidum, valeriana officinalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70476-0004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_X]  in 1 mL
    AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE3 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN6 [hp_X]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID6 [hp_X]  in 1 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70476-0004-159 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/10/2019
    Labeler - Holistic Haven (005153286)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(70476-0004) , api manufacture(70476-0004) , label(70476-0004) , pack(70476-0004)
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