Instant Calm Spray (rescue Remedy Spray)

SPL v2

SPL

SPL Set ID 2abee2c1-1f9f-af2e-e063-6294a90a6afb

Route

ORAL

Published

Effective Date 2015-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Helianthemum Nummularium Flower (30 mL) Impatiens Glandulifera Flower (5 [hp_X]) Clematis Vitalba Flower Ornithogalum Umbellatum Bulb Prunus Cerasifera Flower

Inactive Ingredients

Alcohol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2015-01-01

Description

How to use: Apply 2 sprays onto the tongue. Additional sprays may be taken as needed.

Medication Information

Warnings and Precautions

Warnings:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Indications and Usage

Use for:

Temporarily relieves nervousness, frustration, sleeplessness, and stress.

Temporarily supports calm, comfort, and focus.*

Dosage and Administration

How to use:

Apply 2 sprays onto the tongue. Additional sprays may be taken as needed.

Description

How to use: Apply 2 sprays onto the tongue. Additional sprays may be taken as needed.

Section 50565-1

Warnings:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Section 51727-6

Ingredients:

Inactive: Alcohol Base to Preserve Remedy

Section 51945-4

entire package label

Section 55105-1

Use for:

Temporarily relieves nervousness, frustration, sleeplessness, and stress.

Temporarily supports calm, comfort, and focus.*

Section 55106-9

Active Ingredients:

Cherry Plum (Prunus Cerasifera)

Clematis (Clematis Vitalba)

Impatiens (Impatiens Glandulifera)

Rock Rose (Helianthemum Nummularium)

Star of Bethlehem (Ornithogalum Umbellatum)

Structured Label Content

Indications and Usage (34067-9)

Use for:

Temporarily relieves nervousness, frustration, sleeplessness, and stress.

Temporarily supports calm, comfort, and focus.*

Dosage and Administration (34068-7)

How to use:

Apply 2 sprays onto the tongue. Additional sprays may be taken as needed.

Warnings and Precautions (34071-1)

Warnings:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Section 50565-1 (50565-1)

Warnings:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Section 51727-6 (51727-6)

Ingredients:

Inactive: Alcohol Base to Preserve Remedy

Section 51945-4 (51945-4)

entire package label

Section 55105-1 (55105-1)

Use for:

Temporarily relieves nervousness, frustration, sleeplessness, and stress.

Temporarily supports calm, comfort, and focus.*

Section 55106-9 (55106-9)

Active Ingredients:

Cherry Plum (Prunus Cerasifera)

Clematis (Clematis Vitalba)

Impatiens (Impatiens Glandulifera)

Rock Rose (Helianthemum Nummularium)

Star of Bethlehem (Ornithogalum Umbellatum)

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "30", "strengthDenominator": "30", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HELIANTHEMUM NUMMULARIUM FLOWER", "unii": "51BRR32WPP", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "30", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "IMPATIENS GLANDULIFERA FLOWER", "unii": "AJU5O1A5ZV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "30", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CLEMATIS VITALBA FLOWER", "unii": "7SCP4N87CI", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "30", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ORNITHOGALUM UMBELLATUM BULB", "unii": "48TG5UWC7Z", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "30", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PRUNUS CERASIFERA FLOWER", "unii": "0KD7R09EAS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "30", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use for: Temporarily relieves nervousness, frustration, sleeplessness, and stress. Temporarily supports calm, comfort, and focus.*", "34068-7": "How to use: Apply 2 sprays onto the tongue. Additional sprays may be taken as needed.", "34071-1": "Warnings: Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.", "50565-1": "Warnings: Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.", "51727-6": "Ingredients: Inactive: Alcohol Base to Preserve Remedy", "51945-4": "entire package label", "55105-1": "Use for: Temporarily relieves nervousness, frustration, sleeplessness, and stress. Temporarily supports calm, comfort, and focus.*", "55106-9": "Active Ingredients: Cherry Plum (Prunus Cerasifera) Clematis (Clematis Vitalba) Impatiens (Impatiens Glandulifera) Rock Rose (Helianthemum Nummularium) Star of Bethlehem (Ornithogalum Umbellatum)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:03.419330 · Updated: 2026-03-14T23:17:24.422888