DailyMed - DailyMed Details

SPL v2

SPL

SPL Set ID eedab4b9-509b-3fe5-e053-2995a90a2027

Route

ORAL

Published

Effective Date 2022-12-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Eucalyptus Globulus Leaf (2 [hp_X]) Phosphorus (6 [hp_X]) Ipecac (3 [hp_X]) Bryonia Alba Root (4 [hp_X]) Eupatorium Perfoliatum Flowering Top (1 [hp_X]) Gelsemium Sempervirens Root Pelargonium Sidoides Root Aconitum Napellus

Inactive Ingredients

Maltodextrin Alcohol Xylitol Silicon Dioxide Malic Acid Lactose Monohydrate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Completed Since 2022-12-06 Until 2026-12-31

Description

Dosage & Administration, Warnings, Indications and Usage, added for initial submission in 12/2022. When expiring marketing dates in version 2, SPL could not find original file file name that included an & in file name.

Medication Information

Recent Major Changes

Dosage & Administration, Warnings, Indications and Usage, added for initial submission in 12/2022.

When expiring marketing dates in version 2, SPL could not find original file file name that included an & in file name.

Indications and Usage

Purpose

Description

Section 51945-4

Stop Use

Warnings

Overdosage

Ask A Doctor

Active Ingredients

Inactive Ingredient

Dosage & Administration

Pregnancy Or Breast Feeding

Keep Out of Reach of Children.

Keep out of reach of children.

Structured Label Content

Section 51945-4 (51945-4)

Purpose

Stop Use

Warnings

Overdosage

Ask A Doctor (Ask a Doctor)

Active Ingredients

Inactive Ingredient

Recent Major Changes

Dosage & Administration, Warnings, Indications and Usage, added for initial submission in 12/2022.

When expiring marketing dates in version 2, SPL could not find original file file name that included an & in file name.

Indications and Usage

Dosage & Administration

Pregnancy Or Breast Feeding (Pregnancy or breast feeding)

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.

Advanced Ingredient Data

[{"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS GLOBULUS LEAF", "unii": "S546YLW6E6", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORUS", "unii": "27YLU75U4W", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "IPECAC", "unii": "62I3C8233L", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALIC ACID", "unii": "817L1N4CKP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BRYONIA ALBA ROOT", "unii": "T7J046YI2B", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUPATORIUM PERFOLIATUM FLOWERING TOP", "unii": "1W0775VX6E", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "GELSEMIUM SEMPERVIRENS ROOT", "unii": "639KR60Q1Q", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PELARGONIUM SIDOIDES ROOT", "unii": "H6J53HEX8E", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "ACONITUM NAPELLUS", "unii": "U0NQ8555JD", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Recent Major Changes": "Dosage & Administration, Warnings, Indications and Usage, added for initial submission in 12/2022. When expiring marketing dates in version 2, SPL could not find original file file name that included an & in file name.", "Keep out of reach of children.": "Keep out of reach of children."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:01.840163 · Updated: 2026-03-14T23:17:20.751290