C27

C27
SPL v1
SPL
SPL Set ID a7e345fb-c4aa-4b10-8074-9d8c37304142
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (3 [hp_X]) Gelsemium Sempervirens Root (4 [hp_X]) Amaryllis Belladonna Whole (6 [hp_X]) Strychnos Nux-vomica Seed (8 [hp_X]) Spigelia Anthelmia Whole (12 [hp_X]) Coffea Arabica Seed, Roasted Lycopodium Clavatum Spore Lachesis Muta Venom Pulsatilla Montana Whole Nitroglycerin Chloride Ion
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Allium cepa 3X Gelsemium sempervirens 3X Belladonna 4X Nux vomica 4X Spigelia anthelmia 4X Coffea tosta 6X Lycopodium clavatum 6X Lachesis mutus 8X Pulsatilla 8X Glonoinum 12X Natrum muriaticum 12X


Medication Information

Description

Allium cepa 3X Gelsemium sempervirens 3X Belladonna 4X Nux vomica 4X Spigelia anthelmia 4X Coffea tosta 6X Lycopodium clavatum 6X Lachesis mutus 8X Pulsatilla 8X Glonoinum 12X Natrum muriaticum 12X

Label

Est 1985

Professional Formulas

Complementary Health

Headache 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 occasional headaches.*

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

Allium cepa 3X

Gelsemium sempervirens 3X

Belladonna 4X

Nux vomica 4X

Spigelia anthelmia 4X

Coffea tosta 6X

Lycopodium clavatum 6X

Lachesis mutus 8X

Pulsatilla 8X

Glonoinum 12X

Natrum muriaticum 12X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Headache 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 occasional headaches.*

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)

Allium cepa 3X

Gelsemium sempervirens 3X

Belladonna 4X

Nux vomica 4X

Spigelia anthelmia 4X

Coffea tosta 6X

Lycopodium clavatum 6X

Lachesis mutus 8X

Pulsatilla 8X

Glonoinum 12X

Natrum muriaticum 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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