R223 - DailyMed Details

R223

SPL v1

SPL

SPL Set ID 9790600a-929b-48ce-af11-4b7157c2d31a

Route

ORAL

Published

Effective Date 2019-10-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Black Cohosh (2 [hp_X]) Gelsemium Sempervirens Root (3 [hp_X]) Toxicodendron Pubescens Leaf (6 [hp_X])

Inactive Ingredients

Alcohol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Cimicifuga racemosa 2X, 10X, 30X, 200X Gelsemium sempervirens 3X, 10X, 30X, 200X, 1000X Rhus toxicodendron 6X, 10X, 30X, 200X

Medication Information

Description

Cimicifuga racemosa 2X, 10X, 30X, 200X Gelsemium sempervirens 3X, 10X, 30X, 200X, 1000X Rhus toxicodendron 6X, 10X, 30X, 200X

Label

Est 1985

Professional Formulas

Complementary Health

Gelsemium Combination

Homeopathic Remedy

1 FL. OZ. (29.5 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 occasional headache, exhaustion, or minor body aches.*

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

Cimicifuga racemosa 2X, 10X, 30X, 200X

Gelsemium sempervirens 3X, 10X, 30X, 200X, 1000X

Rhus toxicodendron 6X, 10X, 30X, 200X

Inactive Ingredients

40% ethanol, purified water.

Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Gelsemium Combination

Homeopathic Remedy

1 FL. OZ. (29.5 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 occasional headache, exhaustion, or minor body aches.*

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)

Cimicifuga racemosa 2X, 10X, 30X, 200X

Gelsemium sempervirens 3X, 10X, 30X, 200X, 1000X

Rhus toxicodendron 6X, 10X, 30X, 200X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.

Advanced Ingredient Data

[{"name": "BLACK COHOSH", "unii": "K73E24S6X9", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "GELSEMIUM SEMPERVIRENS ROOT", "unii": "639KR60Q1Q", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "TOXICODENDRON PUBESCENS LEAF", "unii": "6IO182RP7A", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"LABEL": "Est 1985 Professional Formulas Complementary Health Gelsemium Combination Homeopathic Remedy 1 FL. OZ. (29.5 mL)", "50565-1": "Keep out of the reach of children.", "53414-9": "If pregnant or breastfeeding, ask a healthcare professional before use.", "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 occasional headache, exhaustion, or minor body aches.*", "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": "Cimicifuga racemosa 2X, 10X, 30X, 200X Gelsemium sempervirens 3X, 10X, 30X, 200X, 1000X Rhus toxicodendron 6X, 10X, 30X, 200X", "INACTIVE INGREDIENTS": "40% ethanol, purified water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:05.846594 · Updated: 2026-03-14T23:15:18.792040