HELLEBORUS NIGER globule

Helleborus Niger by

Drug Labeling and Warnings

Helleborus Niger by is a Homeopathic medication manufactured, distributed, or labeled by True Botanica, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Helleborus Niger 29X, HPUS

The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

Homeopathic support for the mind (low mental focus, dark moods, etc.) and the body (healthy prostate function, immune system, more). May also be used for standard homeopathic indications or as directed by your physician.

Use:

Homeopathic support for the mind (low mental focus, dark moods, etc.) and the body (healthy prostate function, immune system, more). May also be used for standard homeopathic indications or as directed by your physician.

Warnings:

Consult your health care provider if symptoms persist more than 5 days or worsen.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

DO NOT USE

TAMPER EVIDENT: Do not use if safety seal is broken before first use.

Directions for Use:

Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

Other Ingredients:

Sucrose

QUESTIONS

Developed and Made by

True Botanica, LLC

1005 Richards Rd., Suite D

Hartland, WI 53029

800-315-8783

www.truebotanica.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

HELLEBORUS NIGER 
helleborus niger globule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53645-2080
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	29 [hp_X]  in 23 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53645-2080-2	23 g in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/03/2014

Labeler - True Botanica, LLC (182071519)

Establishment
Name	Address	ID/FEI	Business Operations
True Botanica, LLC		182071519	manufacture(53645-2080)