C93 - DailyMed Details

C93

SPL v1

SPL

SPL Set ID 5852af9f-2e9c-413c-aad8-7688e2626f1c

Route

ORAL

Published

Effective Date 2019-10-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Pancrelipase Amylase (2 [hp_X]) Cellulase (trichoderma Longibrachiatum) (6 [hp_X]) Pancrelipase Lipase Phosphate Ion Pepsin Betaine Tripe Comfrey Root

Inactive Ingredients

Alcohol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Amylase 2X Cellulase 2X Lipase 2X Natrum phosphoricum 2X Pepsinum 2X Betainum muriaticum 6X Stomach 6X Symphytum officinale 6X

Medication Information

Description

Amylase 2X Cellulase 2X Lipase 2X Natrum phosphoricum 2X Pepsinum 2X Betainum muriaticum 6X Stomach 6X Symphytum officinale 6X

Label

Est 1985

Professional Formulas

Complementary Health

Stomach Enzyme 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 indigestion, gas, bloating, or mild abdominal pain or cramping.*

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

Amylase 2X

Cellulase 2X

Lipase 2X

Natrum phosphoricum 2X

Pepsinum 2X

Betainum muriaticum 6X

Stomach 6X

Symphytum officinale 6X

Inactive Ingredients

20% ethanol, purified water.

Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Stomach Enzyme 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 indigestion, gas, bloating, or mild abdominal pain or cramping.*

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)

Amylase 2X

Cellulase 2X

Lipase 2X

Natrum phosphoricum 2X

Pepsinum 2X

Betainum muriaticum 6X

Stomach 6X

Symphytum officinale 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.

Advanced Ingredient Data

[{"name": "PANCRELIPASE AMYLASE", "unii": "YOJ58O116E", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CELLULASE (TRICHODERMA LONGIBRACHIATUM)", "unii": "7Q170212NX", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PANCRELIPASE LIPASE", "unii": "8MYC33932O", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PHOSPHATE ION", "unii": "NK08V8K8HR", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PEPSIN", "unii": "GID333S43J", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "BETAINE", "unii": "3SCV180C9W", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "TRIPE", "unii": "C46FS57S0X", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "59", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "COMFREY ROOT", "unii": "M9VVZ08EKQ", "classCode": "ACTIB", "strengthNumerator": "6", "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 Stomach Enzyme 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 indigestion, gas, bloating, or mild abdominal pain or cramping.*", "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": "Amylase 2X Cellulase 2X Lipase 2X Natrum phosphoricum 2X Pepsinum 2X Betainum muriaticum 6X Stomach 6X Symphytum officinale 6X", "INACTIVE INGREDIENTS": "20% ethanol, purified water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:06.781560 · Updated: 2026-03-14T23:15:20.220550