HELLEBORUS NIGER- helleborus niger root pellet

Helleborus niger by

Drug Labeling and Warnings

Helleborus niger by is a Homeopathic medication manufactured, distributed, or labeled by Washington Homeopathic Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

HELLEBORUS NIG

USES

To relieve the symptoms of muscle weakness.

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of reach of children.

INDICATIONS

Indications:

HELLEBORUS NIG   Muscle weakness

STOP USE AND ASK DOCTOR

If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

DIRECTIONS

Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.  Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

INACTIVE INGREDIENTS

Sucrose/Lactose

PRINCIPAL DISPLAY PANEL

The OTC potency range of HELLEBORUS NIG is 3x–30x, 2c–30c, 200c, 1m, 10m, 50m, and CM.

Availability is subject to change.

All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled.

‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice.

Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce.

INGREDIENTS AND APPEARANCE

HELLEBORUS NIGER 
helleborus niger root pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68428-422
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815)	HELLEBORUS NIGER ROOT	30 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white (white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68428-422-03	75 in 1 VIAL, GLASS; Type 0: Not a Combination Product	02/03/2010
2	NDC: 68428-422-05	150 in 1 VIAL, GLASS; Type 0: Not a Combination Product	02/03/2010
3	NDC: 68428-422-11	300 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/03/2010
4	NDC: 68428-422-12	600 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/03/2010
5	NDC: 68428-422-06	1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/03/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/03/2010

Labeler - Washington Homeopathic Products (084929389)

Establishment
Name	Address	ID/FEI	Business Operations
Washington Homeopathic Products		084929389	manufacture(68428-422)