NDC | 57955-0423-2 |
Set ID | e6c65ffe-d225-4f58-9f9e-e0a656ed16f8 |
Category | HUMAN OTC DRUG LABEL |
Packager | King Bio Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients: Aconitum napellus, Aethusa cynapium, Alfalfa, Aurum metallicum, Avena sativa, Baryta carbonica, Chamomilla, Ignatia amara, Impatiens glandulifera, flos, Kali phosphoricum, Laurocerasus, Natrum phosphoricum, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Staphysagria, Stramonium. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.
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INDICATIONS & USAGE
Uses for temporary relief of symptoms:
- stress
- minor anxiety
- fear
- irritability
- nervousness
- agitation
- mood swings
- worry
- restlessness
- nervous stomach
- oversensitivity
- whining
- emotional overexcitement
- performance anxiety
- anger
- difficulty concentrating
- inconsolable
- overwhelmed
† as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Initially, depress pump until primed.
- Spray one dose directly into mouth.
- 2 to 6 years: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved.
- 6 to 12 Years: 2 sprays, every 15 minutes, up to 8 doses, then hourly until relieved.
- 12 years & older: 3 sprays, every 15 minutes, up to 8 doses, then hourly until relieved.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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PURPOSE
Drug Facts_________________________________________________________________________________________________
HPUS* active ingredients Purpose†
Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.
Aconitum napellus........................................emotional overexcitement
Aethusa cynapium.....................................................inability to focus
Alfalfa..............................................................gloominess, irritability
Aurum metallicum.................................overstimulated, noise-sensitive
Avena sativa....................................................difficulty concentrating
Baryta carbonica........................................confusion, loss of confidence
Chamomilla.......................................oversensitivity, whining, agitation
Ignatia amara....................................................mood changes, worry
Impatiens glandulifera, flos.............................overwhelmed, impatient
Kali phosphoricum.............................................startles easily, anxiety
Laurocerasus...................................................anger if misunderstood
Natrum phosphoricum.................................................nighttime fears
Passiflora incarnata..................................................nervous stomach
Phosphorus..............................................performance anxiety, stress
Prunus cerasifera, flos..................................anxiousness, restlessness
Staphysagria.....................................................irritable nervousness
Stramonium..............................................mood swings, inconsolable
*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIDS STRESS AND ANXIETY
aconitum napellus, aethusa cynapium, alfalfa, aurum metallicum, avena sativa, baryta carbonica, chamomilla, ignatia amara, impatiens glandulifera, flos, kali phosphoricum, laurocerasus, natrum phosphoricum, passiflora incarnata, phosphorus, prunus cerasifera, flos, staphysagria, stramonium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0423 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 10 [hp_X] in 59 mL AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM 10 [hp_X] in 59 mL ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA 10 [hp_X] in 59 mL GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD 10 [hp_X] in 59 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 10 [hp_X] in 59 mL BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE 10 [hp_X] in 59 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X] in 59 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 10 [hp_X] in 59 mL IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER 10 [hp_X] in 59 mL POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 10 [hp_X] in 59 mL PRUNUS LAUROCERASUS LEAF (UNII: F26P2D4757) (PRUNUS LAUROCERASUS LEAF - UNII:F26P2D4757) PRUNUS LAUROCERASUS LEAF 10 [hp_X] in 59 mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 10 [hp_X] in 59 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 10 [hp_X] in 59 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] in 59 mL PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER 10 [hp_X] in 59 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 10 [hp_X] in 59 mL DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0423-2 1 in 1 CARTON 09/01/2016 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2016 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-0423)