helleborus comp. a

helleborus comp. a
SPL v3
SPL
SPL Set ID 150e57ad-3ed7-5cc9-e063-6394a90a25fe
Route
oral
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tin (12 [hp_X]) phosphorus (17 [hp_X]) arsenic cation (3+) (20 [hp_X]) lead (8 [hp_X]) silver (6 [hp_X]) formica rufa (3 [hp_X]) antimony (7 [hp_X]) helleborus niger root phosphate ion juglans regia leaf
Inactive Ingredients
water sodium chloride lactose, unspecified form

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2021-03-11

Description

Use: Temporary relief of headache.


Medication Information

Warnings and Precautions

Warnings:

NOT FOR INJECTION

Do not use if allergic to any ingredient. Contains traces of lactose. Consult a physician if symptoms worsen. If pregnant or nursing, consult a physician before use.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredient

Active Ingredients: Helleborus (Christmas rose) 3X, Formica (Red wood ant) 6X, Kalium phos.(potassium dihydrogenphosphate) 6X,Stibium met. (Antimony) 6X, Juglans reg. e fol. et fruct (walnut) 7X, Argentum met. (Silver) 8X, Phosphorus (Yellow phosphorus) 12X, Arsenicum (White arsenic) 17X, Plumbum silicicum (Lead silicate) 20X

Indications and Usage

FOR ORAL USE ONLY

Dosage and Administration

Directions: Take the contents of one ampule under

the tongue and hold for 30 seconds, then swallow.

Follow inside instructions to open ampule.

Description

Use: Temporary relief of headache.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive Ingredients: Water, Salt, Lactose

Prepared using rhythmical processes.

Section 51945-4

Section 53413-1

Questions? Call 866.642.2858

Uriel, East Troy, WI 53120

shopuriel.com Lot:

Section 55105-1

Use: Temporary relief of headache.


Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

NOT FOR INJECTION

Do not use if allergic to any ingredient. Contains traces of lactose. Consult a physician if symptoms worsen. If pregnant or nursing, consult a physician before use.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredient (55106-9)

Active Ingredients: Helleborus (Christmas rose) 3X, Formica (Red wood ant) 6X, Kalium phos.(potassium dihydrogenphosphate) 6X,Stibium met. (Antimony) 6X, Juglans reg. e fol. et fruct (walnut) 7X, Argentum met. (Silver) 8X, Phosphorus (Yellow phosphorus) 12X, Arsenicum (White arsenic) 17X, Plumbum silicicum (Lead silicate) 20X

Indications and Usage (34067-9)

FOR ORAL USE ONLY

Dosage and Administration (34068-7)

Directions: Take the contents of one ampule under

the tongue and hold for 30 seconds, then swallow.

Follow inside instructions to open ampule.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive Ingredients: Water, Salt, Lactose

Prepared using rhythmical processes.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 866.642.2858

Uriel, East Troy, WI 53120

shopuriel.com Lot:

Section 55105-1 (55105-1)

Use: Temporary relief of headache.


Advanced Ingredient Data


Raw Label Data

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