Label: RSQ FIVE JUNIOR- aconitum napellus, arnica montana, chamomilla, gelsemium sempervirens, ignatia amara, melissa officinalis, phosphoricum acidum, clematis vitalba flower, helianthemum nummularium, impatiens glandulifera flower, ornithogalum umbellatum flower, prunus cerasifera flower, 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 26, 2017

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

  • DRUG FACTS (OTC-ACTIVE INGREDIENT SECTION)

    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 SECTION)

    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 A 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, Flavorant.

  • PRINCIPLE DISPLAY PANEL- 150 TABLET BOTTLE CARTON

    RSQ FIVE JUNIOR TABLETS CARTON

  • INGREDIENTS AND APPEARANCE
    RSQ FIVE JUNIOR 
    aconitum napellus, arnica montana, chamomilla, gelsemium sempervirens, ignatia amara, melissa officinalis, phosphoricum acidum, clematis vitalba flower, helianthemum nummularium, impatiens glandulifera flower, ornithogalum umbellatum flower, prunus cerasifera flower, tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70773-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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]
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [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]
    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]
    GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K) GELSEMIUM SEMPERVIRENS WHOLE60 [hp_X]  in 100 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CROSCARMELLOSE (UNII: 029TFK992N)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70773-102-151 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) Ltd.638215520manufacture(70773-102)