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

RSQ FIVE by

Drug Labeling and Warnings

RSQ FIVE by is a Homeopathic medication manufactured, distributed, or labeled by PRIVATE LABEL BRANDS CC, Herbal and Homeopathic (Pty) Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70773-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	60 [hp_X]  in 100 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	60 [hp_X]  in 100 [hp_X]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X]  in 100 [hp_X]
ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B)	ORNITHOGALUM UMBELLATUM FLOWERING TOP	5 [hp_X]  in 100 [hp_X]
IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV)	IMPATIENS GLANDULIFERA FLOWER	5 [hp_X]  in 100 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	60 [hp_X]  in 100 [hp_X]
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	3 [hp_X]  in 100 [hp_X]
PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS)	PRUNUS CERASIFERA FLOWER	5 [hp_X]  in 100 [hp_X]
GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K)	GELSEMIUM SEMPERVIRENS WHOLE	60 [hp_X]  in 100 [hp_X]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X]  in 100 [hp_X]
HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP)	HELIANTHEMUM NUMMULARIUM FLOWER	5 [hp_X]  in 100 [hp_X]
CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI)	CLEMATIS VITALBA FLOWER	5 [hp_X]  in 100 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70773-103-30	1 in 1 CARTON	12/25/2017
1		1 [hp_X] in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/25/2017

Labeler - PRIVATE LABEL BRANDS CC (539043103)

Registrant - PRIVATE LABEL BRANDS CC (539043103)

Establishment
Name	Address	ID/FEI	Business Operations
Herbal and Homeopathic (Pty) Ltd.		638215520	manufacture(70773-103)