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Panic Button

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Panic Button


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Panic Button  Formulated for symptoms associated with extreme or sudden panic such as shock, anxiety, tension, stress or fear.

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Apis mel. 15x, Arnica 15x, Arsenicum alb. 15x, Belladonna 15x, Bellis 15x, Bryonia 15x, Calendula 15x, Chamomilla 15x, Cistus canadensis 15x, Ferrum phosphoricum 15x, Histaminum hydrochloricum 15x, Hypericum 15x, Ignatia 15x, Mezereum 15x, Ornithogalum 15x, Passiflora 15x, Phosphorus 15x, Prunus spin. 15x, Rhus toxicodendron 15x, Sarcolacticum ac. 15x, Sulphur 15x, Veratrum alb. 15x, Chamomilla 3x, Valeriana 3x.

OTC - PURPOSE SECTION

 Formulated for symptoms associated with extreme or sudden panic such as shock, anxiety, tension, stress or fear.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

Panic Button

Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana PELLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-1115
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS ACONITUM NAPELLUS 15 [hp_X]
APIS MELLIFERA APIS MELLIFERA 15 [hp_X]
ARNICA MONTANA ARNICA MONTANA 15 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 15 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 15 [hp_X]
BELLIS PERENNIS Bellis Perennis 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP 15 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 15 [hp_X]
Helianthemum Canadense Helianthemum Canadense 15 [hp_X]
FERROSOFERRIC PHOSPHATE Ferrosoferric Phosphate 15 [hp_X]
HISTAMINE DIHYDROCHLORIDE Histamine 15 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 15 [hp_X]
STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED 15 [hp_X]
Daphne Mezereum Bark Daphne Mezereum Bark 15 [hp_X]
ORNITHOGALUM UMBELLATUM ORNITHOGALUM UMBELLATUM 15 [hp_X]
Passiflora Incarnata Flowering Top PASSIFLORA INCARNATA FLOWERING TOP 15 [hp_X]
PHOSPHORUS PHOSPHORUS 15 [hp_X]
PRUNUS SPINOSA FLOWER BUD Prunus Spinosa Flower Bud 15 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 15 [hp_X]
LACTIC ACID, L- LACTIC ACID, L- 15 [hp_X]
SULFUR SULFUR 15 [hp_X]
VERATRUM ALBUM ROOT VERATRUM ALBUM ROOT 15 [hp_X]
Valerian VALERIAN 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-1115-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-1115-2 56.7 in 1 BOTTLE, GLASS
3 NDC:55714-1115-0 7.08 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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