C148

C148
SPL v1
SPL
SPL Set ID 373252f3-bbf5-48f1-b2d0-e089c793b18a
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia Whole (1 [hp_X]) Artemisia Annua Flowering Top (3 [hp_X]) Phytolacca Americana Root (4 [hp_X]) Bryonia Alba Root (6 [hp_X]) Bos Taurus Lymph Vessel (12 [hp_X]) Sus Scrofa Mammary Gland (30 [hp_X]) Helianthemum Canadense Arnica Montana Whole Aethusa Cynapium Whole Sanguinaria Canadensis Root Oyster Shell Calcium Carbonate, Crude Conium Maculatum Flowering Top Onosmodium Virginianum Scabies Lesion Lysate (human)
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Echinacea angustifolia 1X Chamomilla 3X Phytolacca decandra 4X Bryonia 6X Chamomilla 6X Lymph 6X Mammary 6X Cistus canadensis 6X, 12X, 30X Arnica montana 6X, 12X, 30X, 60X Aethusa cynapium 12X Sanguinaria canadensis 12X Calcarea carbonica 30X Conium maculatum 30X Onosmodium virginianum 30X Psorinum 30X, 60X, 100X


Medication Information

Description

Echinacea angustifolia 1X Chamomilla 3X Phytolacca decandra 4X Bryonia 6X Chamomilla 6X Lymph 6X Mammary 6X Cistus canadensis 6X, 12X, 30X Arnica montana 6X, 12X, 30X, 60X Aethusa cynapium 12X Sanguinaria canadensis 12X Calcarea carbonica 30X Conium maculatum 30X Onosmodium virginianum 30X Psorinum 30X, 60X, 100X

Label

Est 1985

Professional Formulas

Complementary Health

Fibrous Breast Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Section 50565-1

Keep out of the reach of children.

Section 53414-9

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

Section 55105-1

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

Warnings

Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age. Not intended for use in infants.

Indications

For the temporary relief of swollen, tender, sore, or painful breasts.*

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Active Ingredients

Echinacea angustifolia 1X

Chamomilla 3X

Phytolacca decandra 4X

Bryonia 6X

Chamomilla 6X

Lymph 6X

Mammary 6X

Cistus canadensis 6X, 12X, 30X

Arnica montana 6X, 12X, 30X, 60X

Aethusa cynapium 12X

Sanguinaria canadensis 12X

Calcarea carbonica 30X

Conium maculatum 30X

Onosmodium virginianum 30X

Psorinum 30X, 60X, 100X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Fibrous Breast Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Warnings (WARNINGS)

Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions (DIRECTIONS)

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age. Not intended for use in infants.

Indications (INDICATIONS)

For the temporary relief of swollen, tender, sore, or painful breasts.*

Other Information (OTHER INFORMATION)

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Active Ingredients (ACTIVE INGREDIENTS)

Echinacea angustifolia 1X

Chamomilla 3X

Phytolacca decandra 4X

Bryonia 6X

Chamomilla 6X

Lymph 6X

Mammary 6X

Cistus canadensis 6X, 12X, 30X

Arnica montana 6X, 12X, 30X, 60X

Aethusa cynapium 12X

Sanguinaria canadensis 12X

Calcarea carbonica 30X

Conium maculatum 30X

Onosmodium virginianum 30X

Psorinum 30X, 60X, 100X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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