C113

C113
SPL v1
SPL
SPL Set ID 4a0b233a-a069-47bc-a696-1bebdb172ca4
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Horse Chestnut (3 [hp_X]) Helianthus Annuus Flowering Top (4 [hp_X]) Passiflora Incarnata Flower (30 [hp_X]) Sepia Esculenta Bone
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

So-Lo-Tzu 3X Hsiang-Jih-Kuei-Hua-Pan 3X, 6X Ji-Qing-Hua 4X Wu-Tsei-Ku 30X


Medication Information

Description

So-Lo-Tzu 3X Hsiang-Jih-Kuei-Hua-Pan 3X, 6X Ji-Qing-Hua 4X Wu-Tsei-Ku 30X

Label

Est 1985

Professional Formulas

Complementary Health

Schizophrenia Formula

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. Consult a doctor immediately if symptoms persist or are accompanied by hallucinations or thoughts of harming self or others. 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 confusion, memory loss, disorientation, anxiousness, feelings of anger or fear, or mood swings.*

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

So-Lo-Tzu 3X

Hsiang-Jih-Kuei-Hua-Pan 3X, 6X

Ji-Qing-Hua 4X

Wu-Tsei-Ku 30X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Schizophrenia Formula

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. Consult a doctor immediately if symptoms persist or are accompanied by hallucinations or thoughts of harming self or others. 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 confusion, memory loss, disorientation, anxiousness, feelings of anger or fear, or mood swings.*

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)

So-Lo-Tzu 3X

Hsiang-Jih-Kuei-Hua-Pan 3X, 6X

Ji-Qing-Hua 4X

Wu-Tsei-Ku 30X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)