FDA.reportPublic FDA data

Panic Ease

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-09-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:35:07

Label at a glance#

ProductPanic Ease
Active ingredientACONITUM NAPELLUS, APIS MELLIFERA, ARNICA MONTANA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BELLIS PERENNIS, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA CHAMOMILLA, HELIANTHEMUM CANADENSE, FERROSOFERRIC PHOSPHATE, HISTAMINE DIHYDROCHLORIDE, HYPERICUM PERFORATUM, STRYCHNOS IGNATII SEED, DAPHNE MEZEREUM BARK, ORNITHOGALUM UMBELLATUM, PASSIFLORA INCARNATA FLOWERING TOP, PHOSPHORUS, PRUNUS SPINOSA FLOWER BUD, TOXICODENDRON PUBESCENS LEAF, LACTIC ACID, L-, SULFUR, VERATRUM ALBUM ROOT, VALERIAN
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as fellings of panic, anxiety, tension or fear.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Valeriana 6x, 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.

OTC - PURPOSE SECTION

Formulated for symptoms such as fellings of panic, anxiety, tension or fear.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4766-1Panic Ease30 mL in 1 BOTTLE, GLASSLIQUID303

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-476655714-4766-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BELLIS PERENNIS2HU33I03UYACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
HELIANTHEMUM CANADENSE46G3W789Q3ACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
ORNITHOGALUM UMBELLATUM9NS3M2Y78SACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
PHOSPHORUS27YLU75U4WACTIB
PRUNUS SPINOSA FLOWER BUD53Y84VPS2WACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
LACTIC ACID, L-F9S9FFU82NACTIB
SULFUR70FD1KFU70ACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB
VALERIANJWF5YAW3QWACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Panic EaseACONITUM 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.Newton Laboratories, Inc.9971a152-0706-8166-e053-2995a90aab9f2025-09-23WarningsExact identifier
ndc (package): 55714-4766-1
ndc (product): 55714-4766
ndc11 (package): 55714476601
spl id: 3f7e4182-7b80-1f88-e063-6294a90a603b
spl set id: 9971a152-0706-8166-e053-2995a90aab9f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.