C35

C35
SPL v1
SPL
SPL Set ID 49dcc73f-2a20-4938-8671-0fa9dd39d5b8
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Artemisia Annua Flowering Top (1 [hp_X]) Valerian (2 [hp_X]) Avena Sativa Flowering Top (3 [hp_X]) Zinc (6 [hp_X]) Passiflora Incarnata Flowering Top (24 [hp_X]) Arabica Coffee Bean Paullinia Cupana Seed
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Chamomilla 1X Valeriana officinalis 1X Avena sativa 2X Zincum metallicum 3X Passiflora incarnata 6X Coffea cruda 6X, 12X, 30X Paullinia sorbilis 24X


Medication Information

Description

Chamomilla 1X Valeriana officinalis 1X Avena sativa 2X Zincum metallicum 3X Passiflora incarnata 6X Coffea cruda 6X, 12X, 30X Paullinia sorbilis 24X

Label

Est 1985

Professional Formulas

Complementary Health

Insomnia 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

In case of overdose, get medical help or contact a poison control center right away.

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 difficulty falling or staying asleep.*

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

Chamomilla 1X

Valeriana officinalis 1X

Avena sativa 2X

Zincum metallicum 3X

Passiflora incarnata 6X

Coffea cruda 6X, 12X, 30X

Paullinia sorbilis 24X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Insomnia 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)

In case of overdose, get medical help or contact a poison control center right away.

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 difficulty falling or staying asleep.*

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)

Chamomilla 1X

Valeriana officinalis 1X

Avena sativa 2X

Zincum metallicum 3X

Passiflora incarnata 6X

Coffea cruda 6X, 12X, 30X

Paullinia sorbilis 24X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)