Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 624f35db-291e-4e7f-a2c9-ae319717157a
Route
ORAL
Published
Effective Date 2016-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Myrrh (3 [hp_X]) Fenugreek Seed (6 [hp_X]) Pinus Sylvestris Leafy Twig (8 [hp_X]) Sus Scrofa Lymph (12 [hp_X]) Sus Scrofa Spleen Conium Maculatum Flowering Top Echinacea Angustifolia Calcium Sulfide Hydrangea Arborescens Root Phytolacca Americana Root Silicon Dioxide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-04-25

Description

Myrrha 3X, Trigonella foenum-graecum 3X, Pinus sylvestris 6X, Lymph (suis) 8X, Spleen (suis) 8X, Conium maculatum 12X, Echinacea (Angustifolia) 12X, Hepar sulphuris calcareum 12X, Hydrangea arborescens 12X, Phytolacca decandra 12X, Silicea 12X


Medication Information

Description

Myrrha 3X, Trigonella foenum-graecum 3X, Pinus sylvestris 6X, Lymph (suis) 8X, Spleen (suis) 8X, Conium maculatum 12X, Echinacea (Angustifolia) 12X, Hepar sulphuris calcareum 12X, Hydrangea arborescens 12X, Phytolacca decandra 12X, Silicea 12X

Section 53413-1

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Warnings:

If pregnant or breast-feeding, ask a health care 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.

Directions:

10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

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

Indications:

For temporary relief of swollen tonsils or sore throat and swollen irritable breasts prior to menses.

Active Ingredients:

Myrrha 3X, Trigonella foenum-graecum 3X, Pinus sylvestris 6X, Lymph (suis) 8X, Spleen (suis) 8X, Conium maculatum 12X, Echinacea (Angustifolia) 12X, Hepar sulphuris calcareum 12X, Hydrangea arborescens 12X, Phytolacca decandra 12X, Silicea 12X

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

BIOActive Nutritional

LYMPHOPLEX

HOMEOPATHIC

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

Section 53413-1 (53413-1)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health care 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.

Directions: (DIRECTIONS:)

10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

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

Indications: (INDICATIONS:)

For temporary relief of swollen tonsils or sore throat and swollen irritable breasts prior to menses.

Active Ingredients: (ACTIVE INGREDIENTS:)

Myrrha 3X, Trigonella foenum-graecum 3X, Pinus sylvestris 6X, Lymph (suis) 8X, Spleen (suis) 8X, Conium maculatum 12X, Echinacea (Angustifolia) 12X, Hepar sulphuris calcareum 12X, Hydrangea arborescens 12X, Phytolacca decandra 12X, Silicea 12X

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

LYMPHOPLEX

HOMEOPATHIC

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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