C121 - DailyMed Details

C121

SPL v1

SPL

SPL Set ID 901dfa0f-343b-4385-8b25-7e41a1a7cd1d

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 (1 [hp_X]) Ferula Assa-foetida Resin (3 [hp_X]) Dicentra Canadensis Root (6 [hp_X]) Hyoscyamus Niger (4 [hp_X]) Ferula Sumbul Root Valerian Cicuta Virosa Whole Strychnos Ignatii Seed Gaultheria Procumbens Top Delphinium Staphisagria Seed

Inactive Ingredients

Alcohol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Avena sativa 1X Asafoetida 3X Corydalis canadensis 3X Hyoscyamus niger 3X Sumbul 6X Valeriana officinalis 3X Cicuta virosa 4X Ignatia amara 4X Olei gaultheria procumbens 4X Staphysagria 4X

Medication Information

Description

Avena sativa 1X Asafoetida 3X Corydalis canadensis 3X Hyoscyamus niger 3X Sumbul 6X Valeriana officinalis 3X Cicuta virosa 4X Ignatia amara 4X Olei gaultheria procumbens 4X Staphysagria 4X

Label

Est 1985

Professional Formulas

Complementary Health

Distress 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 feeling distressed or a tendency towards overreaction.*

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 1X

Asafoetida 3X

Corydalis canadensis 3X

Hyoscyamus niger 3X

Sumbul 6X

Valeriana officinalis 3X

Cicuta virosa 4X

Ignatia amara 4X

Olei gaultheria procumbens 4X

Staphysagria 4X

Inactive Ingredients

20% ethanol, purified water.

Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Distress 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 feeling distressed or a tendency towards overreaction.*

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 1X

Asafoetida 3X

Corydalis canadensis 3X

Hyoscyamus niger 3X

Sumbul 6X

Valeriana officinalis 3X

Cicuta virosa 4X

Ignatia amara 4X

Olei gaultheria procumbens 4X

Staphysagria 4X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.

Advanced Ingredient Data

[{"name": "AVENA SATIVA FLOWERING TOP", "unii": "MA9CQJ3F7F", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "FERULA ASSA-FOETIDA RESIN", "unii": "W9FZA51AS1", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "DICENTRA CANADENSIS ROOT", "unii": "Y5JS7YM46F", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "HYOSCYAMUS NIGER", "unii": "4WRK2153H3", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "FERULA SUMBUL ROOT", "unii": "GLA4808EHQ", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "VALERIAN", "unii": "JWF5YAW3QW", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CICUTA VIROSA WHOLE", "unii": "3E698BL84C", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS IGNATII SEED", "unii": "1NM3M2487K", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "GAULTHERIA PROCUMBENS TOP", "unii": "830295X963", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "DELPHINIUM STAPHISAGRIA SEED", "unii": "00543AP1JV", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "59", "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 Distress Drops Homeopathic Remedy 2 FL. OZ. (59 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 feeling distressed or a tendency towards overreaction.*", "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 1X Asafoetida 3X Corydalis canadensis 3X Hyoscyamus niger 3X Sumbul 6X Valeriana officinalis 3X Cicuta virosa 4X Ignatia amara 4X Olei gaultheria procumbens 4X Staphysagria 4X", "INACTIVE INGREDIENTS": "20% ethanol, purified water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:06.546616 · Updated: 2026-03-14T23:15:20.220550