Throat Spray Tone

Throat Spray Tone
SPL v8
SPL
SPL Set ID 19a66388-3288-4fbd-85de-403654b22a95
Route
ORAL
Published
Effective Date 2020-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Apis Mellifera (12 [hp_X]) Baptisia Tinctoria (4 [hp_X]) Atropa Belladonna (15 [hp_X]) Calendula Officinalis Flowering Top (5 [hp_X]) Calcium Sulfide Goldenseal Lachesis Muta Venom Mercurius Solubilis Myrrh Phytolacca Americana Root Acmella Oleracea Flowering Top
Inactive Ingredients
Alcohol Water Glycerin Thymus Serpyllum Clove Mentha Piperita Sage Acmella Oleracea Flower

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-11-03

Description

Active ingredients ​ 59.1 mL contains 9% of: Apis mel 12X; Baptisia 4X; Belladonna 12X; Calendula officinalis 4X; Hepar sulph calc 15X; Hydrastis 5X; Lachesis 12X; Merc solub 12X; Myrrha 5X; Phytolacca 4X; Spilanthes 5X. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Warnings and Precautions

Warnings

  • Sore throat warning:Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.
  • 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.
Indications and Usage

Uses For the temporary relief of minor sore throats.

Dosage and Administration

Directions

  • Three sprays 4-6 times daily or as directed by a healthcare professional. Shake well before use.
  • 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 9% of: Apis mel 12X; Baptisia 4X; Belladonna 12X; Calendula officinalis 4X; Hepar sulph calc 15X; Hydrastis 5X; Lachesis 12X; Merc solub 12X; Myrrha 5X; Phytolacca 4X; Spilanthes 5X. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1
  • Keep out of reach of children.

Section 51727-6

Inactive ingredients

  • Clove, Alcohol, Vegetable Glycerin, Peppermint, Purified Water, Sage, Spilanthes, Wild Thyme.

Section 51945-4

energetix

Throat Spray Tone

Homeopathic Remedy

For the temporary relief of minor sore throats.

2 fl oz (59.1 mL) / 20% Alcohol

Section 53413-1

Distributed by

Energetix Corp.

Dahlonega, GA 30533

Questions? Comments?

800.990.7085

www.energetix.com

Section 55105-1

​Purpose For the temporary relief of minor sore throats.

Section 55106-9

Active ingredients ​ 59.1 mL contains 9% of: Apis mel 12X; Baptisia 4X; Belladonna 12X; Calendula officinalis 4X; Hepar sulph calc 15X; Hydrastis 5X; Lachesis 12X; Merc solub 12X; Myrrha 5X; Phytolacca 4X; Spilanthes 5X.

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.

Structured Label Content

Indications and Usage (34067-9)

Uses For the temporary relief of minor sore throats.

Dosage and Administration (34068-7)

Directions

  • Three sprays 4-6 times daily or as directed by a healthcare professional. Shake well before use.
  • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.

Warnings and Precautions (34071-1)

Warnings

  • Sore throat warning:Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.
  • 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.
Section 50565-1 (50565-1)
  • Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

  • Clove, Alcohol, Vegetable Glycerin, Peppermint, Purified Water, Sage, Spilanthes, Wild Thyme.

Section 51945-4 (51945-4)

energetix

Throat Spray Tone

Homeopathic Remedy

For the temporary relief of minor sore throats.

2 fl oz (59.1 mL) / 20% Alcohol

Section 53413-1 (53413-1)

Distributed by

Energetix Corp.

Dahlonega, GA 30533

Questions? Comments?

800.990.7085

www.energetix.com

Section 55105-1 (55105-1)

​Purpose For the temporary relief of minor sore throats.

Section 55106-9 (55106-9)

Active ingredients ​ 59.1 mL contains 9% of: Apis mel 12X; Baptisia 4X; Belladonna 12X; Calendula officinalis 4X; Hepar sulph calc 15X; Hydrastis 5X; Lachesis 12X; Merc solub 12X; Myrrha 5X; Phytolacca 4X; Spilanthes 5X.

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.

Advanced Ingredient Data


Raw Label Data

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