C55

C55
SPL v1
SPL
SPL Set ID 50cf1c24-4ae9-42e8-a2a3-4d83cc5bfb5a
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (1 [hp_X]) Artemisia Annua Flowering Top (2 [hp_X]) Hops (6 [hp_X]) Valerian (12 [hp_X]) Passiflora Incarnata Flowering Top Scutellaria Lateriflora Whole Gelsemium Sempervirens Root Strychnos Ignatii Seed Pulsatilla Montana Whole Zinc
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Avena sativa 1X Chamomilla 1X Humulus lupulus 1X Valeriana officinalis 1X Passiflora incarnata 2X Scutellaria lateriflora 2X Gelsemium sempervirens 6X Ignatia amara 6X Pulsatilla 6X Zincum metallicum 12X


Medication Information

Description

Avena sativa 1X Chamomilla 1X Humulus lupulus 1X Valeriana officinalis 1X Passiflora incarnata 2X Scutellaria lateriflora 2X Gelsemium sempervirens 6X Ignatia amara 6X Pulsatilla 6X Zincum metallicum 12X

Label

Est 1985

Professional Formulas

Complementary Health

Neuro Relax 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 anxiousness, restlessness, racing thoughts, excessive worry, poor concentration, or stress.*

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

Avena sativa 1X

Chamomilla 1X

Humulus lupulus 1X

Valeriana officinalis 1X

Passiflora incarnata 2X

Scutellaria lateriflora 2X

Gelsemium sempervirens 6X

Ignatia amara 6X

Pulsatilla 6X

Zincum metallicum 12X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Neuro Relax 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 anxiousness, restlessness, racing thoughts, excessive worry, poor concentration, or stress.*

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)

Avena sativa 1X

Chamomilla 1X

Humulus lupulus 1X

Valeriana officinalis 1X

Passiflora incarnata 2X

Scutellaria lateriflora 2X

Gelsemium sempervirens 6X

Ignatia amara 6X

Pulsatilla 6X

Zincum metallicum 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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