Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c
Route
ORAL
Published
Effective Date 2022-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia Whole (1 [hp_X]) Clove (2 [hp_X]) Glycerin (3 [hp_X]) Myrrh (4 [hp_X]) Sage (6 [hp_X]) Acmella Oleracea Flowering Top (12 [hp_X]) Thymus Serpyllum (15 [hp_X]) Baptisia Tinctoria Root Phytolacca Americana Root Goldenseal Apis Mellifera Atropa Belladonna Lachesis Muta Venom Mercurius Solubilis Calcium Sulfide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-03-13 Until 2028-10-03

Description

(in each spray): 6.67% of Echinacea (Angustifolia) 1X, Eugenia Caryophyllata 1X, Glycerinum 1X, Myrrha 2X, Salvia Officinalis 2X, Spilanthes Oleracea 2X, Thymus Serpyllum 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 6X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.


Medication Information

Description

(in each spray): 6.67% of Echinacea (Angustifolia) 1X, Eugenia Caryophyllata 1X, Glycerinum 1X, Myrrha 2X, Salvia Officinalis 2X, Spilanthes Oleracea 2X, Thymus Serpyllum 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 6X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

Warnings:

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

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 physician.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579  800.869.8078

Directions:

Adults and children spray orally 4-6 times daily or as otherwise directed by a health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve swollen sensation, minor throat pain, and burning of the throat.**

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

Active Ingredients:

(in each spray): 6.67% of Echinacea (Angustifolia) 1X, Eugenia Caryophyllata 1X, Glycerinum 1X, Myrrha 2X, Salvia Officinalis 2X, Spilanthes Oleracea 2X, Thymus Serpyllum 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 6X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

Inactive Ingredients:

Demineralized Water, 20% Ethanol, Glycerin.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

THROAT

SPRAY

2 fl. oz. (60 ml)

Keep Out of Reach of Children:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings: (WARNINGS:)

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

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 physician.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579  800.869.8078

Directions: (DIRECTIONS:)

Adults and children spray orally 4-6 times daily or as otherwise directed by a health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve swollen sensation, minor throat pain, and burning of the throat.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each spray): 6.67% of Echinacea (Angustifolia) 1X, Eugenia Caryophyllata 1X, Glycerinum 1X, Myrrha 2X, Salvia Officinalis 2X, Spilanthes Oleracea 2X, Thymus Serpyllum 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 6X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 20% Ethanol, Glycerin.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

THROAT

SPRAY

2 fl. oz. (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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