C120

C120
SPL v1
SPL
SPL Set ID 31644007-d0a9-4482-a6b4-555b70686a72
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eugenol (3 [hp_X]) Ulmus Rubra Bark (4 [hp_X]) Artemisia Annua Flowering Top (6 [hp_X]) Mentha X Piperita Whole (12 [hp_X]) Clematis Recta Flowering Top Citrullus Colocynthis Fruit Pulp Copper Myrrh Bryonia Alba Root Oyster Shell Calcium Carbonate, Crude
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Eugenol 3X Ulmus fulva 3X Chamomilla 3X, 6X, 12X Mentha piperita 4X Clematis erecta 6X Colocynthis 6X Cuprum metallicum 6X Myrrha 6X Bryonia 12X, 30X Calcarea carbonica 12X, 30X


Medication Information

Description

Eugenol 3X Ulmus fulva 3X Chamomilla 3X, 6X, 12X Mentha piperita 4X Clematis erecta 6X Colocynthis 6X Cuprum metallicum 6X Myrrha 6X Bryonia 12X, 30X Calcarea carbonica 12X, 30X

Label

Est 1985

Professional Formulas

Complementary Health

Teething 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 accompanied by fever and symptoms such as lethargy, lack of appetite, vomiting, or diarrhea. 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 for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Indications

For temporary relief of pain or irritability associated with teething.*

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

Eugenol 3X

Ulmus fulva 3X

Chamomilla 3X, 6X, 12X

Mentha piperita 4X

Clematis erecta 6X

Colocynthis 6X

Cuprum metallicum 6X

Myrrha 6X

Bryonia 12X, 30X

Calcarea carbonica 12X, 30X

Inactive Ingredients

10% ethanol, purified water, 8% vegetable glycerin (from soy).


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Teething 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 accompanied by fever and symptoms such as lethargy, lack of appetite, vomiting, or diarrhea. 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 for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

For temporary relief of pain or irritability associated with teething.*

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)

Eugenol 3X

Ulmus fulva 3X

Chamomilla 3X, 6X, 12X

Mentha piperita 4X

Clematis erecta 6X

Colocynthis 6X

Cuprum metallicum 6X

Myrrha 6X

Bryonia 12X, 30X

Calcarea carbonica 12X, 30X

Inactive Ingredients (INACTIVE INGREDIENTS)

10% ethanol, purified water, 8% vegetable glycerin (from soy).


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)