HELLEBORUS COMP. A liquid

Helleborus comp. A by

Drug Labeling and Warnings

Helleborus comp. A by is a Homeopathic medication manufactured, distributed, or labeled by Uriel Pharmacy Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Use: Temporary relief of headache.

INDICATIONS & USAGE

FOR ORAL USE ONLY

DOSAGE & ADMINISTRATION

Directions: Take the contents of one ampule under
the tongue and hold for 30 seconds, then swallow.
Follow inside instructions to open ampule.

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

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

INACTIVE INGREDIENT

Inactive Ingredients: Water, Salt, Lactose

Prepared using rhythmical processes.

QUESTIONS

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com Lot:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HELLEBORUS COMP. A 
helleborus comp. a liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-5135
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC CATION (3+)	17 [hp_X]  in 1 mL
LEAD MONOSILICATE (UNII: TLE92T7F1J) (LEAD - UNII:2P299V784P)	LEAD MONOSILICATE	20 [hp_X]  in 1 mL
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	8 [hp_X]  in 1 mL
FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5)	FORMICA RUFA	6 [hp_X]  in 1 mL
ANTIMONY (UNII: 9IT35J3UV3) (ANTIMONY - UNII:9IT35J3UV3)	ANTIMONY	6 [hp_X]  in 1 mL
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815)	HELLEBORUS NIGER ROOT	3 [hp_X]  in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, MONOBASIC	6 [hp_X]  in 1 mL
JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105)	JUGLANS REGIA LEAF	7 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-5135-1	10 in 1 BOX	03/11/2021
1		1 mL in 1 AMPULE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/11/2021

Labeler - Uriel Pharmacy Inc. (043471163)

Establishment
Name	Address	ID/FEI	Business Operations
Uriel Pharmacy Inc.		043471163	manufacture(48951-5135)