C116

C116
SPL v1
SPL
SPL Set ID 178a5115-06c1-4048-832d-b0cdde7bf45b
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Papaya (1 [hp_X]) Scutellaria Baicalensis Root (2 [hp_X]) Datura Metel Flower (3 [hp_X]) Aconitum Carmichaeli Lateral Root (4 [hp_X]) Ranunculus Bulbosus Root
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Mu-Kua 1X Huang-Chin 2X Yang-Chin-Hua 3X Fu-Tzu 4X Mao-Chua-Tsao 4X


Medication Information

Description

Mu-Kua 1X Huang-Chin 2X Yang-Chin-Hua 3X Fu-Tzu 4X Mao-Chua-Tsao 4X

Label

Est 1985

Professional Formulas

Complementary Health

Delirium 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

Severe or persistent symptoms may be serious. Consult a doctor promptly. 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 or disorientation, memory loss, disorganized thinking, 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

Mu-Kua 1X

Huang-Chin 2X

Yang-Chin-Hua 3X

Fu-Tzu 4X

Mao-Chua-Tsao 4X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Delirium 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)

Severe or persistent symptoms may be serious. Consult a doctor promptly. 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 or disorientation, memory loss, disorganized thinking, 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)

Mu-Kua 1X

Huang-Chin 2X

Yang-Chin-Hua 3X

Fu-Tzu 4X

Mao-Chua-Tsao 4X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)