Label: 3 ACUTE STRESS- arnica montana, bellis perennis, passiflora incarnata, valeriana officinalis, arsenicum album, apis mellifica, carcinosin, cistus canadensis, clematis erecta, coffea cruda, ignatia amara, lachesis mutus, magnesia phosphorica, natrum muriaticum, natrum sulphuricum, ornithogalum umbellatum, phosphoricum acidum, salix nigra, staphysagria 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 June 11, 2019

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

  • ACTIVE INGREDIENTS:

    Arnica Montana 3X, 30C, Bellis Perennis 3X, 30C, Passiflora Incarnata 3X, 30C, Valeriana Officinalis 3X, 30C, Arsenicum Album 6X, 30C, Apis Mellifica 30C, Carcinosin 30C, Cistus Canadensis 30C, Clematis Erecta 30C, Coffea Cruda 30C, Ignatia Amara 30C, Lachesis Mutus 30C, Magnesia Phosphorica 30C, Natrum Muriaticum 30C, Natrum Sulphuricum 30C, Ornithogalum Umbellatum 30C, Phosphoricum Acidum 30C, Salix Nigra 30C, Staphysagria 30C.

  • INDICATIONS:

    For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.

  • WARNINGS:

    If symptoms persist or worsen, seek the advice of a healthcare professional.

    Caution: Not recommended for pregnant or lactating women.

    KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Tamper Seal: Sealed for your protection with a clear, full body seal. Do not use if seal is missing or broken.

  • KEEP OUT OF REACH OF CHILDREN:

    KEEP OUT OF REACH OF CHILDREN
    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    One (1) teaspoon twice daily or as otherwise directed by a healthcare professional.
    Consult a physician for use in children under 6 years of age.

  • INDICATIONS:

    For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.

  • INACTIVE INGREDIENTS:

    Citric Acid, Demineralized Water, Ethanol 1.65%, Sodium Benzoate.

  • QUESTIONS:

    Distributed by

    Biotics Research Corporation

    Rosenberg, TX 77471 • (281) 344-0909

  • PACKAGE LABEL DISPLAY:

    Biotics Research Corporation's

    21ST CENTURY
    HOMEOPATHICS
    NDC# 55146-003-01

    HOMEOPATHIC REMEDY

    #3
    Acute Stress

    Water Based
    Formula

    4 fl. oz.
    (120 ml)

    #3 Acute Stress

  • INGREDIENTS AND APPEARANCE
    3 ACUTE STRESS 
    arnica montana, bellis perennis, passiflora incarnata, valeriana officinalis, arsenicum album, apis mellifica, carcinosin, cistus canadensis, clematis erecta, coffea cruda, ignatia amara, lachesis mutus, magnesia phosphorica, natrum muriaticum, natrum sulphuricum, ornithogalum umbellatum, phosphoricum acidum, salix nigra, staphysagria liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55146-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS3 [hp_X]  in 1 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 1 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA30 [hp_C]  in 1 mL
    HUMAN BREAST TUMOR CELL (UNII: C62OO7VD9K) (HUMAN BREAST TUMOR CELL - UNII:C62OO7VD9K) HUMAN BREAST TUMOR CELL30 [hp_C]  in 1 mL
    HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3) HELIANTHEMUM CANADENSE30 [hp_C]  in 1 mL
    CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP30 [hp_C]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN30 [hp_C]  in 1 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [hp_C]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_C]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE30 [hp_C]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_C]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE30 [hp_C]  in 1 mL
    ORNITHOGALUM UMBELLATUM (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM30 [hp_C]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID30 [hp_C]  in 1 mL
    SALIX NIGRA BARK (UNII: QU52J3A5B3) (SALIX NIGRA BARK - UNII:QU52J3A5B3) SALIX NIGRA BARK30 [hp_C]  in 1 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55146-003-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/11/2019
    Labeler - Biotics Research Corporation (092487347)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(55146-003) , api manufacture(55146-003) , label(55146-003) , pack(55146-003)