Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID ed7bf66b-7480-4a43-9d97-e8c63207e4ff
Route
ORAL
Published
Effective Date 2018-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clematis Vitalba Flower (30 [hp_C]) Helianthemum Nummularium Flower Impatiens Glandulifera Flower Ornithogalum Umbellatum Flowering Top Prunus Cerasifera Flower
Inactive Ingredients
Water Glycerin Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-08-25

Description

​Active Ingredients ​59.1 mL contains 20% of: Clematis vitalba, flos 30C (Clematis); Helianthemum nummularium, flos 30C (Rock Rose); Impatiens Glandulifera, flos 30C (Impatiens); Ornithogalum Umbellatum, flos 30C (Star of Bethlehem); Prunus Cerasifera, flos 30C (Cherry Plum). Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Warnings and Precautions

​Warnings

  • In case of overdose, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast feeding, ask a healthcare professional before use.
  • ​Keep out of reach of children.
Indications and Usage

​Uses Temporary relief of agitation, shock, fear.

Dosage and Administration

​Directions

  • Take 30 drops orally twice daily or as directed by a healthcare professional.
  • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.
Description

​Active Ingredients ​59.1 mL contains 20% of: Clematis vitalba, flos 30C (Clematis); Helianthemum nummularium, flos 30C (Rock Rose); Impatiens Glandulifera, flos 30C (Impatiens); Ornithogalum Umbellatum, flos 30C (Star of Bethlehem); Prunus Cerasifera, flos 30C (Cherry Plum). Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1
  • ​KEEP OUT OF THE REACH OF CHILDREN
Section 51727-6

​Inactive Ingredients Ethyl Alcohol, Glycerin, Purified Water

Section 51945-4

energetix

Rescue Calm

Homeopathic Remedy

Agitation, shock, fear.

2 fl oz (59.1 mL) 15% Ethyl Alcohol

Section 53413-1

Distributed by

Energetix Corp.

Dahlonega, GA 30533

Questions? Comments?

800.990.7085

www.goenergetix.com

Section 55105-1

​Purpose Agitation, shock, fear.

Section 55106-9

​Active Ingredients ​59.1 mL contains 20% of: Clematis vitalba, flos 30C (Clematis); Helianthemum nummularium, flos 30C (Rock Rose); Impatiens Glandulifera, flos 30C (Impatiens); Ornithogalum Umbellatum, flos 30C (Star of Bethlehem); Prunus Cerasifera, flos 30C (Cherry Plum).

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 60561-8

Other information

  • Store at room temperature out of direct sunlight.
  • Do not use if neck wrap is broken or missing.
  • Shake well before use.

Structured Label Content

Indications and Usage (34067-9)

​Uses Temporary relief of agitation, shock, fear.

Dosage and Administration (34068-7)

​Directions

  • Take 30 drops orally twice daily or as directed by a healthcare professional.
  • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.
Warnings and Precautions (34071-1)

​Warnings

  • In case of overdose, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast feeding, ask a healthcare professional before use.
  • ​Keep out of reach of children.
Section 50565-1 (50565-1)
  • ​KEEP OUT OF THE REACH OF CHILDREN
Section 51727-6 (51727-6)

​Inactive Ingredients Ethyl Alcohol, Glycerin, Purified Water

Section 51945-4 (51945-4)

energetix

Rescue Calm

Homeopathic Remedy

Agitation, shock, fear.

2 fl oz (59.1 mL) 15% Ethyl Alcohol

Section 53413-1 (53413-1)

Distributed by

Energetix Corp.

Dahlonega, GA 30533

Questions? Comments?

800.990.7085

www.goenergetix.com

Section 55105-1 (55105-1)

​Purpose Agitation, shock, fear.

Section 55106-9 (55106-9)

​Active Ingredients ​59.1 mL contains 20% of: Clematis vitalba, flos 30C (Clematis); Helianthemum nummularium, flos 30C (Rock Rose); Impatiens Glandulifera, flos 30C (Impatiens); Ornithogalum Umbellatum, flos 30C (Star of Bethlehem); Prunus Cerasifera, flos 30C (Cherry Plum).

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 60561-8 (60561-8)

Other information

  • Store at room temperature out of direct sunlight.
  • Do not use if neck wrap is broken or missing.
  • Shake well before use.

Advanced Ingredient Data


Raw Label Data

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