C63

C63
SPL v1
SPL
SPL Set ID 61f8263d-6f72-442f-a09e-57daf7226cc7
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 (2 [hp_X]) Valerian (3 [hp_X]) Apocynum Cannabinum Root (4 [hp_X]) Nutmeg (6 [hp_X]) Coffea Arabica Seed, Roasted (60 [hp_X]) Strychnos Nux-vomica Seed (8 [hp_X]) Tobacco Leaf Wormwood Antimony Cation (3+) Gold Hyoscyamus Niger Gonorrheal Urethral Secretion Human Sucrose Beta-endorphin Human
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Avena sativa 2X Valeriana officinalis 2X Apocynum cannabinum 3X Nux moschata 3X Coffea tosta 3X, 12X, 60X, 100X Nux vomica 3X, 12X, 60X, 100X Tabacum 4X, 12X, 60X, 100X Absinthium 6X Antimonium tartaricum 6X Aurum metallicum 6X, 12X, 30X Hyoscyamus niger 60X Medorrhinum 60X Sucrose 60X Endorphins 8X, 12X, 60X, 100X


Medication Information

Description

Avena sativa 2X Valeriana officinalis 2X Apocynum cannabinum 3X Nux moschata 3X Coffea tosta 3X, 12X, 60X, 100X Nux vomica 3X, 12X, 60X, 100X Tabacum 4X, 12X, 60X, 100X Absinthium 6X Antimonium tartaricum 6X Aurum metallicum 6X, 12X, 30X Hyoscyamus niger 60X Medorrhinum 60X Sucrose 60X Endorphins 8X, 12X, 60X, 100X

Label

Est 1985

Professional Formulas

Complementary Health

Substance Abuse 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 irritability, reduced motivation, cravings, or inability to concentrate due to overindulgence of food or other dietary substances.*

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 2X

Valeriana officinalis 2X

Apocynum cannabinum 3X

Nux moschata 3X

Coffea tosta 3X, 12X, 60X, 100X

Nux vomica 3X, 12X, 60X, 100X

Tabacum 4X, 12X, 60X, 100X

Absinthium 6X

Antimonium tartaricum 6X

Aurum metallicum 6X, 12X, 30X

Hyoscyamus niger 60X

Medorrhinum 60X

Sucrose 60X

Endorphins 8X, 12X, 60X, 100X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Substance Abuse 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 irritability, reduced motivation, cravings, or inability to concentrate due to overindulgence of food or other dietary substances.*

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 2X

Valeriana officinalis 2X

Apocynum cannabinum 3X

Nux moschata 3X

Coffea tosta 3X, 12X, 60X, 100X

Nux vomica 3X, 12X, 60X, 100X

Tabacum 4X, 12X, 60X, 100X

Absinthium 6X

Antimonium tartaricum 6X

Aurum metallicum 6X, 12X, 30X

Hyoscyamus niger 60X

Medorrhinum 60X

Sucrose 60X

Endorphins 8X, 12X, 60X, 100X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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