NDC | 70773-102-15 |
Set ID | 61482eb0-bd23-3bb5-e053-2a91aa0a1529 |
Category | HUMAN OTC DRUG LABEL |
Packager | Private Label Brands CC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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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
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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 (OTC- KEEP OUT OF REACH OF CHILDREN SECTION)
- DIRECTIONS (INDICATIONS & USAGE SECTION)
- OTHER INFORMATION (INSTRUCTIONS FOR USE SECTION)
- WARNING (WARNINGS SECTION)
- STOP USE AND ASK A DOCTOR IF (OTC- STOP USE SECTION)
- IF PREGNANT OR BREASTFEEDING, (OTC-PREGNANCY OR BREAST FEEDING SECTION)
- INACTIVE INGREDIENTS (INACTIVE INGREDIENT SECTION)
- PRINCIPLE DISPLAY PANEL- 150 TABLET BOTTLE CARTON
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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, tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70773-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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] MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [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] 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] GELSEMIUM SEMPERVIRENS WHOLE (UNII: R0519OZO3K) (GELSEMIUM SEMPERVIRENS WHOLE - UNII:R0519OZO3K) GELSEMIUM SEMPERVIRENS WHOLE 60 [hp_X] in 100 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CROSCARMELLOSE (UNII: 029TFK992N) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70773-102-15 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(70773-102)