FDA.reportPublic FDA data

CalmEase Rescue Remedy

Manufacturer
vitality Works | Vitality Works, Inc
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:36:09

Label at a glance#

ProductCalmEase Rescue Remedy
Active ingredientORNITHOGALUM UMBELLATUM, IMPATIENS GLANDULIFERA FLOWER, CLEMATIS VITALBA WHOLE, HELIANTHEMUM NUMMULARIUM FLOWER, PRUNUS CERASIFERA FLOWER
Label structure8 sections

Label contents#

Full prescribing information#

CalmEase Rescue Remedy Formula

OTC - ACTIVE INGREDIENT SECTION

Star of Bethlehem – Orithogalum umbellatum
Rock Rose – Helianthemum
Cherry Plum – Prunus cerasifera
Impatiens – Impatiens gladulifera
Clematis – Clematis vitalba

CalmEase Rescue Remedy Formula

INACTIVE INGREDIENT SECTION

USP Purified Water, Vegetable Glycerin

CalmEase Rescue Remedy Formula

WARNINGS SECTION

Keep out of reach of children.

CalmEase Rescue Remedy Formula

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

CalmEase Rescue Remedy Formula

INDICATIONS & USAGE SECTION

Advanced Anti-Stress Formula

CalmEase Rescue Remedy Formula

DOSAGE & ADMINISTRATION SECTION

4 drops orally 4 times daily or as directed.

OTC - PURPOSE SECTION

Advanced Anti-Stress Formula

CalmEase Rescue Remedy Formula

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CalmEase Rescue Remedy FormulaCalmEase Rescue Remedy Formula

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130848998081034GTIN-13: 0848998081034
EAN-13: 0848998081034
GTIN-12: 848998081034
UPC-A: 848998081034
GTIN storage (14 digits): 00848998081034		CalmEase Rescue Remedy Formula.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-113-01CalmEase Rescue Remedy30 mL in 1 BOTTLE, DROPPERLIQUID307

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-11364616-113-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ORNITHOGALUM UMBELLATUM9NS3M2Y78SACTIB
IMPATIENS GLANDULIFERA FLOWERAJU5O1A5ZVACTIB
GLYCERINPDC6A3C0OXIACT
CLEMATIS VITALBA WHOLE7PH07Z124QACTIB
WATER059QF0KO0RIACT
HELIANTHEMUM NUMMULARIUM FLOWER51BRR32WPPACTIB
PRUNUS CERASIFERA FLOWER0KD7R09EASACTIB

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
CalmEase Rescue RemedyCALMEASE RESCUE REMEDYvitality Works5fb2ddea-169e-3749-e053-2991aa0a76e42025-12-17WarningsExact identifier
ndc (package): 64616-113-01
ndc (product): 64616-113
ndc11 (package): 64616011301
spl id: 462f5967-ef13-2778-e063-6294a90ac4b1
spl set id: 5fb2ddea-169e-3749-e053-2991aa0a76e4

Reported adverse events (FAERS/openFDA)#

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