Panic 1106L-Dis

Drug Labeling and Warnings

Drug Details [pdf]

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. liquid 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Panic 1106L-Dis

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: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop 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: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

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

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. liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-1106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA15 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA15 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA15 [hp_X]  in 1 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP15 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA15 [hp_X]  in 1 mL
HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3) HELIANTHEMUM CANADENSE15 [hp_X]  in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE15 [hp_X]  in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE15 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM15 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED15 [hp_X]  in 1 mL
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK15 [hp_X]  in 1 mL
ORNITHOGALUM UMBELLATUM (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM15 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W) PRUNUS SPINOSA FLOWER BUD15 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L-15 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR15 [hp_X]  in 1 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT15 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-1106-129.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
2NDC: 55714-1106-259.14 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
3NDC: 55714-1106-00.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/201101/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-1106)

Revised: 1/2019