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SPL v2

SPL

SPL Set ID 2d81c13f-102a-6741-e063-6294a90aee84

Route

ORAL

Published

Effective Date 2025-02-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Aconitum Napellus (3 [hp_X]) Bryonia Cretica Subsp. Dioica Root

Inactive Ingredients

Water Alcohol

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2025-02-06

Description

ACONITUM NAPELLUS 3X HPUS BRYONIA CRETICA 3X HPUS

Medication Information

Warnings and Precautions

IF SYMPTOMS PERSIST MORE THAN A FEW DAYS, CONTACT LICENSED PRACTIONER.

Indications and Usage

FOR TEMPORARY RELIEF OF MINOR INFLAMMATION AND TRAUMA

Dosage and Administration

DAY 1; TAKE 5 DROPS ON THE TONGUE EVERY 15 MINUTES FOR 2 HOURS. THEN TAKE 5 DROPS ONCE EVERY HOUR. DAY 2; TAKE 5 DROPS ONCE EVERY HOUR. DAY 3; TAKE 5 DROPS EVERY TWO HOURS. CONTINUE WITH 10 DROPS THREE TIMES DAILY

Description

ACONITUM NAPELLUS 3X HPUS BRYONIA CRETICA 3X HPUS

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

ETHYL ALCOHOL 20% V/V

WATER

Section 51945-4

Section 53414-9

IF PREGNANT OR BREAST-FEEDING, CONSULT A HEALTH PROFESSIONAL BEFORE USE

Section 55105-1

FOR TEMPORARY RELIEF OF MINOR INFLAMMATION AND TRAUMA

Section 55106-9

ACONITUM NAPELLUS 3X HPUS

BRYONIA CRETICA 3X HPUS

Structured Label Content

Indications and Usage (34067-9)

FOR TEMPORARY RELIEF OF MINOR INFLAMMATION AND TRAUMA

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

IF SYMPTOMS PERSIST MORE THAN A FEW DAYS, CONTACT LICENSED PRACTIONER.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

ETHYL ALCOHOL 20% V/V

WATER

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

IF PREGNANT OR BREAST-FEEDING, CONSULT A HEALTH PROFESSIONAL BEFORE USE

Section 55105-1 (55105-1)

FOR TEMPORARY RELIEF OF MINOR INFLAMMATION AND TRAUMA

Section 55106-9 (55106-9)

ACONITUM NAPELLUS 3X HPUS

BRYONIA CRETICA 3X HPUS

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACONITUM NAPELLUS", "unii": "U0NQ8555JD", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "BRYONIA CRETICA SUBSP. DIOICA ROOT", "unii": "53UB5FH7CX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "FOR TEMPORARY RELIEF OF MINOR INFLAMMATION AND TRAUMA", "34068-7": "DAY 1; TAKE 5 DROPS ON THE TONGUE EVERY 15 MINUTES FOR 2 HOURS. THEN TAKE 5 DROPS ONCE EVERY HOUR. DAY 2; TAKE 5 DROPS ONCE EVERY HOUR. DAY 3; TAKE 5 DROPS EVERY TWO HOURS. CONTINUE WITH 10 DROPS THREE TIMES DAILY", "34071-1": "IF SYMPTOMS PERSIST MORE THAN A FEW DAYS, CONTACT LICENSED PRACTIONER.", "50565-1": "KEEP OUT OF REACH OF CHILDREN", "51727-6": "ETHYL ALCOHOL 20% V/V WATER", "53414-9": "IF PREGNANT OR BREAST-FEEDING, CONSULT A HEALTH PROFESSIONAL BEFORE USE", "55105-1": "FOR TEMPORARY RELIEF OF MINOR INFLAMMATION AND TRAUMA", "55106-9": "ACONITUM NAPELLUS 3X HPUS BRYONIA CRETICA 3X HPUS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:11.765349 · Updated: 2026-03-14T23:17:37.584721