Label: RSQ FIVE- aconitum napellus, arnica montana, chamomilla, gelsemium sempervirens, ignatia amara, melissa officinalis, phosphoricum acidum tablet

  • 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)

    Temporarily relieves symptoms associated with emotional and nervous stress, anxiety, trauma, fear, and poor sleeping habits.

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

    KEEP OUT OF REACH OF CHILDREN

  • DIRECTIONS (INDICATIONS & USAGE SECTION)

    Adults and children aged 12 years or older:

    Dissolve 2 tablets in mouth 3x daily. May be taken hourly in acute cases

    Children between 2 and 12 years old:

    Dissolve 1 tablet in mouth 3x daily. May be taken hourly in acute cases.

    Infants: 1 crushed tablet diluted in cooled, boiled, water.

  • OTHER INFORMATION (INSTRUCTIONS FOR USE SECTION)

    Store below 77°F and away from direct sunlight.

  • WARNING (WARNINGS SECTIONS)

    These tablets contain lactose and should be used with caution by individuals with a severe sensitivity or intolerance to lactose 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)

    Lactose monohydrate, crosscarmelose, magnesium stearate

  • Principle Display Panel 150 Tablet Bottle

    RSQ Five Tablets Carton

  • INGREDIENTS AND APPEARANCE
    RSQ FIVE 
    aconitum napellus, arnica montana, chamomilla, gelsemium sempervirens, ignatia amara, melissa officinalis, phosphoricum acidum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70773-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS3 [hp_X]  in 100 [hp_X]
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID60 [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]
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [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]
    PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA 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]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS60 [hp_X]  in 100 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA60 [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]
    IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER5 [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]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE (UNII: 029TFK992N)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70773-101-151 in 1 CARTON12/25/2017
    11 [hp_X] in 1 BOTTLE; 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) LTD638215520manufacture(70773-101)