Label: RSQ FIVE- aconitum napellus, arnica montana, chamomilla, gelsemium sempervirens, ignatia amara, melissa officinalis, phosphoricum acidum, clematis vitalba, helianthemum nummularium, impatiens glandulifera, ornithogalum umbellatum, prunus cerasifera 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 December 27, 2017

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

  • ACTIVE INGREDIENTS (OTC-ACTIVE INGREDIENT SECTION)

    Aconitum napellus D60 HPUS

    Arnica montana D60 HPUS

    Chamomilla (Matricaria recutita) D6 HPUS

    Gelsemium sempervirens D60 HPUS

    Ignatia amara D12 HPUS

    Melissa officinalis D3 HPUS

    Phosphoricum acidum D60 HPUS

    Five Flower Essences 5x containing:

    Clematis vitalba (Clematis) flos. aq. inf.

    Helianthemum nummularium (Rock rose) flos. aq. inf.

    Impatiens glandulifera (Impatiens) flos. aq. inf.

    Ornithogalum umbellatum (Star of Bethlehem) flos. aq. inf.

    Prunus cerasifera (Cherry Plum) flos. aq. inf. HPUS

  • PURPOSE (DOSAGE & ADMINISTRATION SECTION)

    Temporarily relieves fear, extreme anxiety, and panic

    Temporarily relieves dizziness and faintness due to trauma or shock

    Temporarily calms restlessness, insomnia, tension and stress

    Temporarily relieves anticipatory fears, fear of failure and exam fears

    Temporarily relieves symptoms of worry, anxiety or hysteria, after shock, grief, emotions of turmoil

    Temporarily relieves irritability, coping with stress and tension

    Helps to temporarily calm restlessness, insomnia, tension and stress

    The five flower essences are used as first aid for the temporary relief of shock and trauma, extreme fear and panic.

    It works on the nervous system to retain calmness, temporarily relieve restlessness and impatience

  • USES (OTC- PURPOSE SECTION)

  • KEEP OUT OF REACH OF CHILDREN (KEEP OUT OF REACH OF CHILDREN SECTION)

    KEEP OUT OF REACH OF CHILDREN

  • DIRECTIONS (INDICATIONS & USAGE SECTION)

    Adults and children:

    Place 10 drops directly on tongue 3x daily. In severe cases, 10 drops every 15 minutes for an hour, then hourly for 24 hours.

    Infants:

    5 - 10 drops diluted in cooled, boiled, water.

  • OTHER INFORMAITON (INSTRUCTIONS FOR USE SECTION)

    Store below 77 °F and away from direct sunlight

  • WARNING (WARNINGS SECTION)

    These drops contain alcohol and should be used with caution by individuals with a severe sensitivity or intolerance to alcohol as well as diabetics.

  • STOP USE AND ASK DOCTOR IF (OTC- STOP USE SECTION)

    symptoms are severe or the shock or trauma symptoms continue for longer than 24 hours.

  • IF PREGNANT OR BREASTFEEDING, (OTC- PREGNANCY OR BREAST FEEDING SECTION)

    ask a health professional before use.

  • INACTIVE INGREDIENTS (INACTIVE INGREDIENT SECTION)

    Brandy (preservative) 25% alcohol

  • Principle Display Panel-30ml container

    RSQ Five Drops Carton

  • INGREDIENTS AND APPEARANCE
    RSQ FIVE 
    aconitum napellus, arnica montana, chamomilla, gelsemium sempervirens, ignatia amara, melissa officinalis, phosphoricum acidum, clematis vitalba, helianthemum nummularium, impatiens glandulifera, ornithogalum umbellatum, prunus cerasifera liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70773-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID60 [hp_X]  in 100 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS60 [hp_X]  in 100 [hp_X]
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 100 [hp_X]
    ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B) ORNITHOGALUM UMBELLATUM FLOWERING TOP5 [hp_X]  in 100 [hp_X]
    IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER5 [hp_X]  in 100 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA60 [hp_X]  in 100 [hp_X]
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS3 [hp_X]  in 100 [hp_X]
    PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER5 [hp_X]  in 100 [hp_X]
    GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K) GELSEMIUM SEMPERVIRENS WHOLE60 [hp_X]  in 100 [hp_X]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_X]  in 100 [hp_X]
    HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER5 [hp_X]  in 100 [hp_X]
    CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER5 [hp_X]  in 100 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70773-103-301 in 1 CARTON12/25/2017
    11 [hp_X] in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/25/2017
    Labeler - PRIVATE LABEL BRANDS CC (539043103)
    Registrant - PRIVATE LABEL BRANDS CC (539043103)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbal and Homeopathic (Pty) Ltd.638215520manufacture(70773-103)