drug facts:

drug facts:
SPL v4
SPL
SPL Set ID 9ec6f663-5f15-4daf-a36b-49fbe1c53a6c
Route
oral
Published
Effective Date 2022-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
echinacea angustifolia (3 [hp_X]) lomatium dissectum root (6 [hp_X]) goldenseal (12 [hp_X]) sambucus nigra flowering top (30 [hp_X]) aconitum napellus cairina moschata heart/liver autolysate arsenic cation (3+) atropa belladonna bryonia alba root eupatorium perfoliatum flowering top gelsemium sempervirens root 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) lachesis muta venom toxicodendron pubescens leaf rancid beef
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic completed Since 2022-07-20 Until 2027-09-08

Purpose

Aconitum Napellus – Chills,** Anas Barbariae, Hepatis Et Cordis Extractum - minor colds, ** Arsenicum Album - restlessness, ** Belladonna – swelling, ** Bryonia (Alba) - cough, ** Eupatorium Perfoliatum - aches, ** Gelsemium Sempervirens - headache, ** Hydrastis Canadensis – mucous discharge, ** Influenzinum (2021-2022) - fatigue, ** Lachesis Mutus – sore throat, ** Pyrogenium – fever, ** Rhus Tox - soreness, ** Sambucus Nigra – runny nose, ** Echinacea (Angustifolia) - dullness, ** Lomatium Dissectum – rash. ** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop): Aconitum Napellus 12X 7.68%, Anas Barbariae 12X 7.68%, Arsenicum Album 12X 7.68%, Belladonna 12X 7.68%, Bryonia (Alba) 12X 7.68%, Eupatorium Perfoliatum 12X 7.68%, Gelsemium Sempervirens 12X 7.68%, Hydrastis Canadensis 6X 7.68%, Influenzinum (2021-2022) 12X 7.68%, Lachesis Mutus 12X 7.68%, Pyrogenium 30X 7.68%, Rhus Tox 12X 7.68%, Sambucus Nigra 6X 7.68%; Echinacea (Angustifolia) 3X 0.10%, Lomatium Dissectum 3X 0.10%.


Medication Information

Purpose

Aconitum Napellus – Chills,** Anas Barbariae, Hepatis Et Cordis Extractum - minor colds, ** Arsenicum Album - restlessness, ** Belladonna – swelling, ** Bryonia (Alba) - cough, ** Eupatorium Perfoliatum - aches, ** Gelsemium Sempervirens - headache, ** Hydrastis Canadensis – mucous discharge, ** Influenzinum (2021-2022) - fatigue, ** Lachesis Mutus – sore throat, ** Pyrogenium – fever, ** Rhus Tox - soreness, ** Sambucus Nigra – runny nose, ** Echinacea (Angustifolia) - dullness, ** Lomatium Dissectum – rash. ** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop): Aconitum Napellus 12X 7.68%, Anas Barbariae 12X 7.68%, Arsenicum Album 12X 7.68%, Belladonna 12X 7.68%, Bryonia (Alba) 12X 7.68%, Eupatorium Perfoliatum 12X 7.68%, Gelsemium Sempervirens 12X 7.68%, Hydrastis Canadensis 6X 7.68%, Influenzinum (2021-2022) 12X 7.68%, Lachesis Mutus 12X 7.68%, Pyrogenium 30X 7.68%, Rhus Tox 12X 7.68%, Sambucus Nigra 6X 7.68%; Echinacea (Angustifolia) 3X 0.10%, Lomatium Dissectum 3X 0.10%.

Purpose:

Aconitum Napellus – Chills,** Anas Barbariae, Hepatis Et Cordis Extractum - minor colds, ** Arsenicum Album - restlessness, ** Belladonna – swelling, ** Bryonia (Alba) - cough, ** Eupatorium Perfoliatum - aches, ** Gelsemium Sempervirens - headache, ** Hydrastis Canadensis – mucous discharge, ** Influenzinum (2021-2022) - fatigue, ** Lachesis Mutus – sore throat, ** Pyrogenium – fever, ** Rhus Tox - soreness, ** Sambucus Nigra – runny nose, ** Echinacea (Angustifolia) - dullness, ** Lomatium Dissectum – rash. **

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

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 physician.

Stop use and ask a doctor if symptoms persist for more than 2 days.

If pregnant or breast-feeding, 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.

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800-869-8078

Directions:

Adults and children 5 to 10 drops orally, 3 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 temporary relieve fever, runny nose, achiness, or rash.**

**Claims based on traditional homeopathic practice. Not FDA evaluated.

Active Ingredients:

(in each drop):

Aconitum Napellus 12X 7.68%, Anas Barbariae 12X 7.68%, Arsenicum Album 12X 7.68%, Belladonna 12X 7.68%, Bryonia (Alba) 12X 7.68%, Eupatorium Perfoliatum 12X 7.68%, Gelsemium Sempervirens 12X 7.68%, Hydrastis Canadensis 6X 7.68%, Influenzinum (2021-2022) 12X 7.68%, Lachesis Mutus 12X 7.68%, Pyrogenium 30X 7.68%, Rhus Tox 12X 7.68%, Sambucus Nigra 6X 7.68%; Echinacea (Angustifolia) 3X 0.10%, Lomatium Dissectum 3X 0.10%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

LYMPHASTAT V

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

Purpose: (PURPOSE:)

Aconitum Napellus – Chills,** Anas Barbariae, Hepatis Et Cordis Extractum - minor colds, ** Arsenicum Album - restlessness, ** Belladonna – swelling, ** Bryonia (Alba) - cough, ** Eupatorium Perfoliatum - aches, ** Gelsemium Sempervirens - headache, ** Hydrastis Canadensis – mucous discharge, ** Influenzinum (2021-2022) - fatigue, ** Lachesis Mutus – sore throat, ** Pyrogenium – fever, ** Rhus Tox - soreness, ** Sambucus Nigra – runny nose, ** Echinacea (Angustifolia) - dullness, ** Lomatium Dissectum – rash. **

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

Warnings: (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 physician.

Stop use and ask a doctor if symptoms persist for more than 2 days.

If pregnant or breast-feeding, 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.

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING

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, 3 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 temporary relieve fever, runny nose, achiness, or rash.**

**Claims based on traditional homeopathic practice. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop):

Aconitum Napellus 12X 7.68%, Anas Barbariae 12X 7.68%, Arsenicum Album 12X 7.68%, Belladonna 12X 7.68%, Bryonia (Alba) 12X 7.68%, Eupatorium Perfoliatum 12X 7.68%, Gelsemium Sempervirens 12X 7.68%, Hydrastis Canadensis 6X 7.68%, Influenzinum (2021-2022) 12X 7.68%, Lachesis Mutus 12X 7.68%, Pyrogenium 30X 7.68%, Rhus Tox 12X 7.68%, Sambucus Nigra 6X 7.68%; Echinacea (Angustifolia) 3X 0.10%, Lomatium Dissectum 3X 0.10%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

LYMPHASTAT V

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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