C140

C140
SPL v1
SPL
SPL Set ID cdae292a-b331-491d-bb4c-73fc15bfc864
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Spigelia Anthelmia Whole (2 [hp_X]) Cyclamen Purpurascens Tuber (3 [hp_X]) Claviceps Purpurea Sclerotium (4 [hp_X]) Tanacetum Vulgare Top (6 [hp_X]) Amaryllis Belladonna Whole Bryonia Alba Root Gelsemium Sempervirens Root Nitroglycerin Iris Versicolor Root Tanacetum Parthenium Whole
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Spigelia anthelmia 2X Cyclamen europaeum 3X Secale cornutum 3X Tanacetum vulgare 3X Belladonna 4X Bryonia 4X Gelsemium sempervirens 6X Glonoinum 6X Iris versicolor 6X Tanacetum parthenium 6X


Medication Information

Description

Spigelia anthelmia 2X Cyclamen europaeum 3X Secale cornutum 3X Tanacetum vulgare 3X Belladonna 4X Bryonia 4X Gelsemium sempervirens 6X Glonoinum 6X Iris versicolor 6X Tanacetum parthenium 6X

Label

Est 1985

Professional Formulas

Complementary Health

Migraine 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 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 the temporary relief of headache, sensitivity to light or sound, or nausea.*

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

Spigelia anthelmia 2X

Cyclamen europaeum 3X

Secale cornutum 3X

Tanacetum vulgare 3X

Belladonna 4X

Bryonia 4X

Gelsemium sempervirens 6X

Glonoinum 6X

Iris versicolor 6X

Tanacetum parthenium 6X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Migraine 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 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 the temporary relief of headache, sensitivity to light or sound, or nausea.*

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)

Spigelia anthelmia 2X

Cyclamen europaeum 3X

Secale cornutum 3X

Tanacetum vulgare 3X

Belladonna 4X

Bryonia 4X

Gelsemium sempervirens 6X

Glonoinum 6X

Iris versicolor 6X

Tanacetum parthenium 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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