Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID c512f211-f4f8-46f6-87ed-dd50287359df
Route
ORAL
Published
Effective Date 2023-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Geranium Robertianum (3 [hp_X]) Nasturtium Officinale (4 [hp_X]) Teucrium Scorodonia Flowering Top (5 [hp_X]) Equisetum Hyemale (6 [hp_X]) Fumaria Officinalis Flowering Top (8 [hp_X]) Sodium Sulfate Anhydrous (10 [hp_X]) Phytolacca Americana Root (12 [hp_X]) Pinus Sylvestris Leafy Twig Veronica Officinalis Flowering Top Baptisia Tinctoria Root Galium Aparine Gentiana Lutea Root Apis Mellifera Sarsaparilla Barium Cation Calcium Sulfide Mercuric Cyanide Scrophularia Nodosa Aloe Ferrous Iodide Myosotis Arvensis Araneus Diadematus Calcium Cation Juglans Regia Fruit Rind, Immature Juglans Regia Leaf Bos Taurus Parathyroid Gland Silicon Dioxide Sus Scrofa Thymus Sus Scrofa Thyroid
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-12-28

Description

(in each drop) Aloe 8X, 12X 5.19%, Apis Mellifica 6X 5.19%, Aranea Diadema 12X 5.19%, Baptisia Tinctoria 5X 5.19%, Calcarea Phosphorica 12X 5.19%, Ferrum Iodatum 12X 5.19%, Galium Aparine 5X 5.19%, Gentiana Lutea 5X 5.19%, Juglans Regia 12X 5.19%, Myosotis Arvensis 10X 5.19%, Parathyroid Gland 12X 5.19%, Phytolacca Decandra 4X 5.19%, Sarsaparilla 6X 5.19%, Scrophularia Nodosa 8X 5.19%, Silicea 12X 5.19%, Teucrium Scorodonia 6X 5.19%, Thymus 12X 5.19%, Thyroidinum 12X 5.19%, Baryta Carbonica 8X 0.10%, Equisetum Hyemale 4X 0.10%, Ferrum Iodatum 8X 0.10%, Fumaria Officinalis 4X 0.10%, Geranium Robertianum 3X, 4X 0.10%, Hepar Sulphuris Calcareum 8X 0.10%, Mercurius Cyanatus 8X 0.10%, Nasturtium Aquaticum 3X, 4X 0.10%, Natrum Sulphuricum 4X 0.10%, Pinus Sylvestris 4X 0.10%, Teucrium Scorodonia 3X 0.10%, Veronica Officinalis 4X 0.10%.

Purpose

Aloe - bloating,** Apis Mellifica - hives,** Aranea Diadema - chilliness,** Baptisia Tinctoria - confusion,** Calcarea Phosphorica – back pain,** Ferrum Iodatum – enlarged glands,** Galium Aparine - acne,** Gentiana Lutea – low appetite,** Juglans Regia - exhaustion,** Myosotis Arvensis - perspiration,** Parathyroid Gland – aching pains,** Phytolacca Decandra – sore throat,** Sarsaparilla – dry skin,** Scrophularia Nodosa – lymphatic congestion,** Silicea - fatigue,** Teucrium Scorodonia - cough,** Thymus – joint pain,** Thyroidinum - sadness,** Baryta Carbonica – tonsillar swelling,** Equisetum Hyemale – frequent urination,** Fumaria Officinalis – brain fog,** Geranium Robertianum – stomach pain,** Hepar Sulphuris Calcareum – burning pains,** Mercurius Cyanatus - nausea,** Nasturtium Aquaticum - constipation,** Natrum Sulphuricum - headache,** Pinus Sylvestris - stiffness,** Veronica Officinalis – itching.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aloe - bloating,** Apis Mellifica - hives,** Aranea Diadema - chilliness,** Baptisia Tinctoria - confusion,** Calcarea Phosphorica – back pain,** Ferrum Iodatum – enlarged glands,** Galium Aparine - acne,** Gentiana Lutea – low appetite,** Juglans Regia - exhaustion,** Myosotis Arvensis - perspiration,** Parathyroid Gland – aching pains,** Phytolacca Decandra – sore throat,** Sarsaparilla – dry skin,** Scrophularia Nodosa – lymphatic congestion,** Silicea - fatigue,** Teucrium Scorodonia - cough,** Thymus – joint pain,** Thyroidinum - sadness,** Baryta Carbonica – tonsillar swelling,** Equisetum Hyemale – frequent urination,** Fumaria Officinalis – brain fog,** Geranium Robertianum – stomach pain,** Hepar Sulphuris Calcareum – burning pains,** Mercurius Cyanatus - nausea,** Nasturtium Aquaticum - constipation,** Natrum Sulphuricum - headache,** Pinus Sylvestris - stiffness,** Veronica Officinalis – itching.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop) Aloe 8X, 12X 5.19%, Apis Mellifica 6X 5.19%, Aranea Diadema 12X 5.19%, Baptisia Tinctoria 5X 5.19%, Calcarea Phosphorica 12X 5.19%, Ferrum Iodatum 12X 5.19%, Galium Aparine 5X 5.19%, Gentiana Lutea 5X 5.19%, Juglans Regia 12X 5.19%, Myosotis Arvensis 10X 5.19%, Parathyroid Gland 12X 5.19%, Phytolacca Decandra 4X 5.19%, Sarsaparilla 6X 5.19%, Scrophularia Nodosa 8X 5.19%, Silicea 12X 5.19%, Teucrium Scorodonia 6X 5.19%, Thymus 12X 5.19%, Thyroidinum 12X 5.19%, Baryta Carbonica 8X 0.10%, Equisetum Hyemale 4X 0.10%, Ferrum Iodatum 8X 0.10%, Fumaria Officinalis 4X 0.10%, Geranium Robertianum 3X, 4X 0.10%, Hepar Sulphuris Calcareum 8X 0.10%, Mercurius Cyanatus 8X 0.10%, Nasturtium Aquaticum 3X, 4X 0.10%, Natrum Sulphuricum 4X 0.10%, Pinus Sylvestris 4X 0.10%, Teucrium Scorodonia 3X 0.10%, Veronica Officinalis 4X 0.10%.

Uses:

May temporarily relieve symptoms associated with lymphatic congestion, such as: • tendency to catch colds • fluid retention • fatigue.**

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

Purpose:

Aloe - bloating,** Apis Mellifica - hives,** Aranea Diadema - chilliness,** Baptisia Tinctoria - confusion,** Calcarea Phosphorica – back pain,** Ferrum Iodatum – enlarged glands,** Galium Aparine - acne,** Gentiana Lutea – low appetite,** Juglans Regia - exhaustion,** Myosotis Arvensis - perspiration,** Parathyroid Gland – aching pains,** Phytolacca Decandra – sore throat,** Sarsaparilla – dry skin,** Scrophularia Nodosa – lymphatic congestion,** Silicea - fatigue,** Teucrium Scorodonia - cough,** Thymus – joint pain,** Thyroidinum - sadness,** Baryta Carbonica – tonsillar swelling,** Equisetum Hyemale – frequent urination,** Fumaria Officinalis – brain fog,** Geranium Robertianum – stomach pain,** Hepar Sulphuris Calcareum – burning pains,** Mercurius Cyanatus - nausea,** Nasturtium Aquaticum - constipation,** Natrum Sulphuricum - headache,** Pinus Sylvestris - stiffness,** Veronica Officinalis – itching.**

**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 a 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 IOS 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, 3 times daily or as otherwise directed by a health care professional. • Consult a physician for use in children under 12 years of age.

Active Ingredients:

(in each drop) Aloe 8X, 12X 5.19%, Apis Mellifica 6X 5.19%, Aranea Diadema 12X 5.19%, Baptisia Tinctoria 5X 5.19%, Calcarea Phosphorica 12X 5.19%, Ferrum Iodatum 12X 5.19%, Galium Aparine 5X 5.19%, Gentiana Lutea 5X 5.19%, Juglans Regia 12X 5.19%, Myosotis Arvensis 10X 5.19%, Parathyroid Gland 12X 5.19%, Phytolacca Decandra 4X 5.19%, Sarsaparilla 6X 5.19%, Scrophularia Nodosa 8X 5.19%, Silicea 12X 5.19%, Teucrium Scorodonia 6X 5.19%, Thymus 12X 5.19%, Thyroidinum 12X 5.19%, Baryta Carbonica 8X 0.10%, Equisetum Hyemale 4X 0.10%, Ferrum Iodatum 8X 0.10%, Fumaria Officinalis 4X 0.10%, Geranium Robertianum 3X, 4X 0.10%, Hepar Sulphuris Calcareum 8X 0.10%, Mercurius Cyanatus 8X 0.10%, Nasturtium Aquaticum 3X, 4X 0.10%, Natrum Sulphuricum 4X 0.10%, Pinus Sylvestris 4X 0.10%, Teucrium Scorodonia 3X 0.10%, Veronica Officinalis 4X 0.10%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

LYMPHDRAINEX

2 fl. oz. (60 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Uses: (USES:)

May temporarily relieve symptoms associated with lymphatic congestion, such as: • tendency to catch colds • fluid retention • fatigue.**

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

Purpose: (PURPOSE:)

Aloe - bloating,** Apis Mellifica - hives,** Aranea Diadema - chilliness,** Baptisia Tinctoria - confusion,** Calcarea Phosphorica – back pain,** Ferrum Iodatum – enlarged glands,** Galium Aparine - acne,** Gentiana Lutea – low appetite,** Juglans Regia - exhaustion,** Myosotis Arvensis - perspiration,** Parathyroid Gland – aching pains,** Phytolacca Decandra – sore throat,** Sarsaparilla – dry skin,** Scrophularia Nodosa – lymphatic congestion,** Silicea - fatigue,** Teucrium Scorodonia - cough,** Thymus – joint pain,** Thyroidinum - sadness,** Baryta Carbonica – tonsillar swelling,** Equisetum Hyemale – frequent urination,** Fumaria Officinalis – brain fog,** Geranium Robertianum – stomach pain,** Hepar Sulphuris Calcareum – burning pains,** Mercurius Cyanatus - nausea,** Nasturtium Aquaticum - constipation,** Natrum Sulphuricum - headache,** Pinus Sylvestris - stiffness,** Veronica Officinalis – itching.**

**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 a 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 IOS 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, 3 times daily or as otherwise directed by a health care professional. • Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) Aloe 8X, 12X 5.19%, Apis Mellifica 6X 5.19%, Aranea Diadema 12X 5.19%, Baptisia Tinctoria 5X 5.19%, Calcarea Phosphorica 12X 5.19%, Ferrum Iodatum 12X 5.19%, Galium Aparine 5X 5.19%, Gentiana Lutea 5X 5.19%, Juglans Regia 12X 5.19%, Myosotis Arvensis 10X 5.19%, Parathyroid Gland 12X 5.19%, Phytolacca Decandra 4X 5.19%, Sarsaparilla 6X 5.19%, Scrophularia Nodosa 8X 5.19%, Silicea 12X 5.19%, Teucrium Scorodonia 6X 5.19%, Thymus 12X 5.19%, Thyroidinum 12X 5.19%, Baryta Carbonica 8X 0.10%, Equisetum Hyemale 4X 0.10%, Ferrum Iodatum 8X 0.10%, Fumaria Officinalis 4X 0.10%, Geranium Robertianum 3X, 4X 0.10%, Hepar Sulphuris Calcareum 8X 0.10%, Mercurius Cyanatus 8X 0.10%, Nasturtium Aquaticum 3X, 4X 0.10%, Natrum Sulphuricum 4X 0.10%, Pinus Sylvestris 4X 0.10%, Teucrium Scorodonia 3X 0.10%, Veronica Officinalis 4X 0.10%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

LYMPHDRAINEX

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.


Advanced Ingredient Data


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