R243 - DailyMed Details

R243

SPL v1

SPL

SPL Set ID 011790c2-5087-41da-9df7-3fd754b6c73c

Route

ORAL

Published

Effective Date 2019-10-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Saw Palmetto (1 [hp_X]) Chimaphila Umbellata Whole (10 [hp_X]) Calcium Sulfide

Inactive Ingredients

Alcohol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Sabal serrulata 1X, 10X, 30X Chimaphila umbellata 10X, 30X Hepar sulphuris calcareum 10X, 15X, 30X, 200X

Medication Information

Description

Sabal serrulata 1X, 10X, 30X Chimaphila umbellata 10X, 30X Hepar sulphuris calcareum 10X, 15X, 30X, 200X

Label

Est 1985

Professional Formulas

Complementary Health

Sabal 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 mild abdominal pain, diarrhea, constipation, or hemorrhoids.*

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

Sabal serrulata 1X, 10X, 30X

Chimaphila umbellata 10X, 30X

Hepar sulphuris calcareum 10X, 15X, 30X, 200X

Inactive Ingredients

40% ethanol, purified water.

Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Sabal 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 mild abdominal pain, diarrhea, constipation, or hemorrhoids.*

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)

Sabal serrulata 1X, 10X, 30X

Chimaphila umbellata 10X, 30X

Hepar sulphuris calcareum 10X, 15X, 30X, 200X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.

Advanced Ingredient Data

[{"name": "SAW PALMETTO", "unii": "J7WWH9M8QS", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CHIMAPHILA UMBELLATA WHOLE", "unii": "WCK21A9W9J", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "29.5", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CALCIUM SULFIDE", "unii": "1MBW07J51Q", "classCode": "ACTIB", "strengthNumerator": "10", "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 Sabal 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 mild abdominal pain, diarrhea, constipation, or hemorrhoids.*", "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": "Sabal serrulata 1X, 10X, 30X Chimaphila umbellata 10X, 30X Hepar sulphuris calcareum 10X, 15X, 30X, 200X", "INACTIVE INGREDIENTS": "40% ethanol, purified water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:05.798821 · Updated: 2026-03-14T23:15:17.748223