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 
PRIVATE LABEL BRANDS CC

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.

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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

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)

Revised: 12/2017
Document Id: 61566222-27b8-32d2-e053-2a91aa0a11b0
Set id: 61566222-27b7-32d2-e053-2a91aa0a11b0
Version: 1
Effective Time: 20171227
 
PRIVATE LABEL BRANDS CC