FDA.reportPublic FDA data

BM Rescue Remedy (Instant Calm) spray

Manufacturer
BM Private Limited
Effective date
2025-06-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:34:11

Label at a glance#

ProductBM Rescue Remedy (Instant Calm)
Active ingredientHELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS RECTA FLOWERING TOP, IMPATIENS GLANDULIFERA FLOWER, ORNITHOGALUM UMBELLATUM, PRUNUS CERASIFERA FLOWER
Label structure10 sections

Storage and handling

Precautions/storage: Keep away from children and store at cool and dry place.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (Ref. stand.) Cherry plum 5X (HPUS) Clematis erecta 5X (HPUS) Impatiens gland 5X (HPUS) Rock rose 5X (HPUS) Star of bethlehem 5X (HPUS)

INACTIVE INGREDIENT SECTION

Ethanol 30%, Glycerin

OTC - PURPOSE SECTION

Indications: As advised by a homoeopathic physician.

INDICATIONS & USAGE SECTION

Indications: As advised by a homoeopathic physician.

DOSAGE & ADMINISTRATION SECTION

How to use: 2 puff 3 times a day, spray under the tongue. Hold for 30 seconds, and then swallow.

CONTRAINDICATIONS SECTION

Care & contra-indications: This is a homoeopathic remedy, no contra-indications are established.

WARNINGS SECTION

Precautions/storage: Keep away from children and store at cool and dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Precautions/storage: Keep away from children and store at cool and dry place.

STORAGE AND HANDLING SECTION

Precautions/storage: Keep away from children and store at cool and dry place.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Entire package label

rescue remedyrescue remedy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-6025-1BM Rescue Remedy (Instant Calm)30 mL in 1 BOTTLE, SPRAYSPRAY301

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
85816-602585816-6025-1

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
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
HELIANTHEMUM NUMMULARIUM FLOWER51BRR32WPPACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
IMPATIENS GLANDULIFERA FLOWERAJU5O1A5ZVACTIB
ORNITHOGALUM UMBELLATUM9NS3M2Y78SACTIB
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
BM Rescue Remedy (Instant Calm)CLEMATIS ERECTA, CHERRY PLUM, IMPATIENS GLANDULIFERA, ROCK ROSE, STAR OF BETHLEHEMBM Private Limited388ff26a-f735-7247-e063-6294a90a2dde2025-06-27WarningsExact identifier
ndc (package): 85816-6025-1
ndc (product): 85816-6025
ndc11 (package): 85816602501
spl id: 388ff26a-f736-7247-e063-6294a90a2dde
spl set id: 388ff26a-f735-7247-e063-6294a90a2dde

Reported adverse events (FAERS/openFDA)#

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