R220 - DailyMed Details

R220

SPL v1

SPL

SPL Set ID ad44d561-9004-43f1-8271-ef52b715fa66

Route

ORAL

Published

Effective Date 2019-10-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hawthorn Leaf With Flower (1 [hp_X]) Spigelia Anthelmia Whole (2 [hp_X]) Carbonate Ion (3 [hp_X]) Arnica Montana Whole (4 [hp_X]) Selenicereus Grandiflorus Stem (6 [hp_X]) Gelsemium Sempervirens Root (12 [hp_X]) Castor Fiber Scent Gland Secretion Nitroglycerin Ranunculus Bulbosus Whole Sulfur

Inactive Ingredients

Alcohol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Crataegus 1X Spigelia anthelmia 2X Kali carbonicum 3X Arnica montana 4X Cactus grandiflorus 4X Gelsemium sempervirens 4X Castoreum 6X Glonoinum 6X Ranunculus bulbosus 6X Sulphur 12X

Medication Information

Description

Crataegus 1X Spigelia anthelmia 2X Kali carbonicum 3X Arnica montana 4X Cactus grandiflorus 4X Gelsemium sempervirens 4X Castoreum 6X Glonoinum 6X Ranunculus bulbosus 6X Sulphur 12X

Label

Est 1985

Professional Formulas

Complementary Health

Crataegus 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 insomnia, restlessness, or anxiousness.*

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

Crataegus 1X

Spigelia anthelmia 2X

Kali carbonicum 3X

Arnica montana 4X

Cactus grandiflorus 4X

Gelsemium sempervirens 4X

Castoreum 6X

Glonoinum 6X

Ranunculus bulbosus 6X

Sulphur 12X

Inactive Ingredients

40% ethanol, purified water.

Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Crataegus 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 insomnia, restlessness, or anxiousness.*

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)

Crataegus 1X

Spigelia anthelmia 2X

Kali carbonicum 3X

Arnica montana 4X

Cactus grandiflorus 4X

Gelsemium sempervirens 4X

Castoreum 6X

Glonoinum 6X

Ranunculus bulbosus 6X

Sulphur 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.

Advanced Ingredient Data

[{"name": "HAWTHORN LEAF WITH FLOWER", "unii": "6OM09RPY36", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SPIGELIA ANTHELMIA WHOLE", "unii": "WYT05213GE", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CARBONATE ION", "unii": "7UJQ5OPE7D", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ARNICA MONTANA WHOLE", "unii": "O80TY208ZW", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SELENICEREUS GRANDIFLORUS STEM", "unii": "7114SV0MYK", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "GELSEMIUM SEMPERVIRENS ROOT", "unii": "639KR60Q1Q", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CASTOR FIBER SCENT GLAND SECRETION", "unii": "9X8XFD5ZQX", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "NITROGLYCERIN", "unii": "G59M7S0WS3", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "RANUNCULUS BULBOSUS WHOLE", "unii": "AEQ8NXJ0MB", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SULFUR", "unii": "70FD1KFU70", "classCode": "ACTIB", "strengthNumerator": "12", "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 Crataegus 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 insomnia, restlessness, or anxiousness.*", "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": "Crataegus 1X Spigelia anthelmia 2X Kali carbonicum 3X Arnica montana 4X Cactus grandiflorus 4X Gelsemium sempervirens 4X Castoreum 6X Glonoinum 6X Ranunculus bulbosus 6X Sulphur 12X", "INACTIVE INGREDIENTS": "40% ethanol, purified water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:05.853080 · Updated: 2026-03-14T23:15:18.792040