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

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)

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70773-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	3 [hp_X]  in 100 [hp_X]
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	60 [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]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [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]
PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS)	PRUNUS CERASIFERA 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]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	60 [hp_X]  in 100 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	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]
IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV)	IMPATIENS GLANDULIFERA FLOWER	5 [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]

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE (UNII: 029TFK992N)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70773-101-15	1 in 1 CARTON	12/25/2017
1		1 [hp_X] in 1 BOTTLE; 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(70773-101)