Helleborus Niger 12: Homeopathic Product Information

HELLEBORUS NIGER 12- helleborus foetidus root liquid
Uriel Pharmacy Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Directions: FOR ORAL USE.

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

Active Ingredient: Helleborus niger (Christmas rose) 12X

Inactive Ingredients: Water, Salt

Use: Temporary relief of headache.

KEEP OUT OF REACH OF CHILDREN.

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use.

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
www.urielpharmacy.com

Helleborus niger 12X

HELLEBORUS NIGER 12
helleborus niger 12 liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-5114
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELLEBORUS FOETIDUS ROOT (HELLEBORUS FOETIDUS ROOT) HELLEBORUS FOETIDUS ROOT 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:48951-5114-1 8 AMPULE in 1 BOX contains a AMPULE
1 1 mL in 1 AMPULE This package is contained within the BOX (48951-5114-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/01/2009
Labeler — Uriel Pharmacy Inc. (043471163)
Establishment
Name Address ID/FEI Operations
Uriel Pharmacy Inc. 043471163 manufacture (48951-5114)

Revised: 07/2021 Uriel Pharmacy Inc.

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