C16

C16
SPL v1
SPL
SPL Set ID 60e305b4-bb1f-465e-963d-38e6b38df98d
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Passiflora Incarnata Flowering Top (2 [hp_X]) Strychnos Ignatii Seed (3 [hp_X]) Pulsatilla Montana Whole (4 [hp_X]) Chloride Ion (12 [hp_X]) Human Cholecystokinin-33 (60 [hp_X]) Liquid Petroleum Sulfur
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Passiflora incarnata 2X Ignatia amara 3X, 6X, 12X, 60X Pulsatilla 4X Natrum muriaticum 12X Cholecystokinin (CCK) 12X, 30X Petroleum 60X Sulphur 60X


Medication Information

Description

Passiflora incarnata 2X Ignatia amara 3X, 6X, 12X, 60X Pulsatilla 4X Natrum muriaticum 12X Cholecystokinin (CCK) 12X, 30X Petroleum 60X Sulphur 60X

Label

Est 1985

Professional Formulas

Complementary Health

Melancholy Drops Introvert

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

Persistent symptoms may be a sign of a serious condition. If symptoms persist or worsen, consult a doctor. 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. Consult a physician for use in children under 12 years of age.

Indications

For the temporary relief of sadness or fatigue, particularly in those with introverted personality.*

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

Passiflora incarnata 2X

Ignatia amara 3X, 6X, 12X, 60X

Pulsatilla 4X

Natrum muriaticum 12X

Cholecystokinin (CCK) 12X, 30X

Petroleum 60X

Sulphur 60X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Melancholy Drops Introvert

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)

Persistent symptoms may be a sign of a serious condition. If symptoms persist or worsen, consult a doctor. 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. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

For the temporary relief of sadness or fatigue, particularly in those with introverted personality.*

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)

Passiflora incarnata 2X

Ignatia amara 3X, 6X, 12X, 60X

Pulsatilla 4X

Natrum muriaticum 12X

Cholecystokinin (CCK) 12X, 30X

Petroleum 60X

Sulphur 60X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)