C152

C152
SPL v1
SPL
SPL Set ID 55af88df-8e5a-4e84-a8f6-fc3063d91381
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 (3 [hp_X]) Asian Ginseng (6 [hp_X]) Passiflora Incarnata Flowering Top (8 [hp_X]) Schisandrin B, (+/-)- (9 [hp_X]) Amber (12 [hp_X]) Rauwolfia Serpentina (30 [hp_X]) Graphite Aconitum Napellus Whole Barium Cation Phosphorus Arnica Montana Whole Sulfur Arsenic Cation (3+) Mercurius Solubilis Sepia Officinalis Juice
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Chamomilla 3X Panax ginseng 3X Passiflora incarnata 3X Schisandra 3X Succinum 3X Rauwolfia serpentina 6X Graphites 8X Aconitum napellus 9X Baryta carbonica 9X Phosphorus 9X Arnica montana 12X Sulphur 12X Arsenicum album 30X Mercurius solubilis 30X Sepia 30X


Medication Information

Description

Chamomilla 3X Panax ginseng 3X Passiflora incarnata 3X Schisandra 3X Succinum 3X Rauwolfia serpentina 6X Graphites 8X Aconitum napellus 9X Baryta carbonica 9X Phosphorus 9X Arnica montana 12X Sulphur 12X Arsenicum album 30X Mercurius solubilis 30X Sepia 30X

Label

Est 1985

Professional Formulas

Complementary Health

Sleep Disorder 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. Consult a physician for use in children under 12 years of age.

Indications

For the temporary relief of unrestful, interrupted, or inconsistent sleep.*

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 3X

Panax ginseng 3X

Passiflora incarnata 3X

Schisandra 3X

Succinum 3X

Rauwolfia serpentina 6X

Graphites 8X

Aconitum napellus 9X

Baryta carbonica 9X

Phosphorus 9X

Arnica montana 12X

Sulphur 12X

Arsenicum album 30X

Mercurius solubilis 30X

Sepia 30X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Sleep Disorder 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. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

For the temporary relief of unrestful, interrupted, or inconsistent sleep.*

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 3X

Panax ginseng 3X

Passiflora incarnata 3X

Schisandra 3X

Succinum 3X

Rauwolfia serpentina 6X

Graphites 8X

Aconitum napellus 9X

Baryta carbonica 9X

Phosphorus 9X

Arnica montana 12X

Sulphur 12X

Arsenicum album 30X

Mercurius solubilis 30X

Sepia 30X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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