Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 5f3e6e90-3495-4dee-93d2-1a272b075125
Route
ORAL
Published
Effective Date 2022-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chelidonium Majus (3 [hp_X]) Lobelia Inflata (6 [hp_X]) Rumex Crispus Root (8 [hp_X]) Sambucus Nigra Flowering Top (12 [hp_X]) Polygala Senega Root (10 [hp_C]) Spongia Officinalis Skeleton, Roasted (30 [hp_C]) Taraxacum Officinale Virola Sebifera Resin Lobaria Pulmonaria Sulfur Ustilago Maydis Laricifomes Officinalis Fruiting Body Candida Albicans Milk Thistle Crotalus Horridus Horridus Venom Scrophularia Nodosa Amanita Muscaria Fruiting Body Lycoperdon Utriforme Fruiting Body Claviceps Purpurea Sclerotium Cairina Moschata Heart/liver Autolysate Bacillus Anthracis Immunoserum Rabbit Arsenic Cation (3+) Baptisia Tinctoria Root Berberis Vulgaris Root Bark Clostridium Botulinum Shigella Dysenteriae Salmonella Enterica Enterica Serovar Enteritidis Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Hemagglutinin Antigen (formaldehyde Inactivated) Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Hemagglutinin Antigen (formaldehyde Inactivated) Influenza B Virus B/washington/02/2019 Hemagglutinin Antigen (formaldehyde Inactivated) Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated) Vaccinia Virus Human Sputum, Bordetella Pertussis Infected Streptococcus Pneumoniae Rancid Beef Vaccinia Virus Strain New York City Board Of Health Live Antigen
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2022-03-21 Until 2027-04-27

Description

(in each drop) 3.97% of Myristica Sebifera 6X, Sticta Pulmonaria 6X, Sulphur 6X, Ustilago Maidis 6X; Candida Albicans 12X, Carduus Marianus 12X, Crotalus Horridus 12X, Scrophularia Nodosa 12X; Agaricus Muscarius 10C, Bovista 10C, Secale Cornutum 10C; Anas Barbariae, Hepatis ET Cordis Extractum 30C, Anthracinum 30C, Arsenicum Album 30C, Baptisia Tinctoria 30C, Berberis Vulgaris 30C, Botulinum 30C, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C, Influenzinum (2021-2022) 30C, Malandrinum 30C, Pertussinum 30C, Pneumococcinum 30C, Pyrogenium 30C, Variolinum 30C. 0.10% of Chelidonium Majus 3X, Lobelia Inflata 3X, Rumex Crispus 3X, Sambucus Nigra 3X, Senega Officinalis 3X, Spongia Tosta 3X, Taraxacum Officinale 3X; Polyporus Officinalis 8X.


Medication Information

Description

(in each drop) 3.97% of Myristica Sebifera 6X, Sticta Pulmonaria 6X, Sulphur 6X, Ustilago Maidis 6X; Candida Albicans 12X, Carduus Marianus 12X, Crotalus Horridus 12X, Scrophularia Nodosa 12X; Agaricus Muscarius 10C, Bovista 10C, Secale Cornutum 10C; Anas Barbariae, Hepatis ET Cordis Extractum 30C, Anthracinum 30C, Arsenicum Album 30C, Baptisia Tinctoria 30C, Berberis Vulgaris 30C, Botulinum 30C, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C, Influenzinum (2021-2022) 30C, Malandrinum 30C, Pertussinum 30C, Pneumococcinum 30C, Pyrogenium 30C, Variolinum 30C. 0.10% of Chelidonium Majus 3X, Lobelia Inflata 3X, Rumex Crispus 3X, Sambucus Nigra 3X, Senega Officinalis 3X, Spongia Tosta 3X, Taraxacum Officinale 3X; Polyporus Officinalis 8X.

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.

Questions:

Dist. by Energique, Inc., 201 Apple Blvd.

Woodbine, IA 51579 800.869.8078

Directions:

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 2 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve symptoms of fever, cough, swollen glands, or diarrhea.**

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

Active Ingredients:

(in each drop) 3.97% of Myristica Sebifera 6X, Sticta Pulmonaria 6X, Sulphur 6X, Ustilago Maidis 6X; Candida Albicans 12X, Carduus Marianus 12X, Crotalus Horridus 12X, Scrophularia Nodosa 12X; Agaricus Muscarius 10C, Bovista 10C, Secale Cornutum 10C; Anas Barbariae, Hepatis ET Cordis Extractum 30C, Anthracinum 30C, Arsenicum Album 30C, Baptisia Tinctoria 30C, Berberis Vulgaris 30C, Botulinum 30C, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C, Influenzinum (2021-2022) 30C, Malandrinum 30C, Pertussinum 30C, Pneumococcinum 30C, Pyrogenium 30C, Variolinum 30C. 0.10% of Chelidonium Majus 3X, Lobelia Inflata 3X, Rumex Crispus 3X, Sambucus Nigra 3X, Senega Officinalis 3X, Spongia Tosta 3X, Taraxacum Officinale 3X; Polyporus Officinalis 8X.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

BIO-IMMUNE

1 fl. oz. (30 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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc., 201 Apple Blvd.

Woodbine, IA 51579 800.869.8078

Directions: (DIRECTIONS:)

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 2 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve symptoms of fever, cough, swollen glands, or diarrhea.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) 3.97% of Myristica Sebifera 6X, Sticta Pulmonaria 6X, Sulphur 6X, Ustilago Maidis 6X; Candida Albicans 12X, Carduus Marianus 12X, Crotalus Horridus 12X, Scrophularia Nodosa 12X; Agaricus Muscarius 10C, Bovista 10C, Secale Cornutum 10C; Anas Barbariae, Hepatis ET Cordis Extractum 30C, Anthracinum 30C, Arsenicum Album 30C, Baptisia Tinctoria 30C, Berberis Vulgaris 30C, Botulinum 30C, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C, Influenzinum (2021-2022) 30C, Malandrinum 30C, Pertussinum 30C, Pneumococcinum 30C, Pyrogenium 30C, Variolinum 30C. 0.10% of Chelidonium Majus 3X, Lobelia Inflata 3X, Rumex Crispus 3X, Sambucus Nigra 3X, Senega Officinalis 3X, Spongia Tosta 3X, Taraxacum Officinale 3X; Polyporus Officinalis 8X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

BIO-IMMUNE

1 fl. oz. (30 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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