Otc - Purpose
Use: Temporary relief of headache.
The following Structured Product Label (SPL) was submitted to the FDA by Uriel Pharmacy Inc. for the product Helleborus Comp. D (NDC 48951-5151). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, otc - active ingredient, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Use: Temporary relief of headache.
FOR ORAL USE ONLY
Directions: Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow. Follow inside instructions to open ampule.
Warnings:
NOT FOR INJECTION
Do not use if allergic to any ingredient. 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.
Active Ingredients: Hyoscyamus (Henbane) 4X, Helleborus (Christmas rose) 6X, Hepar oryctolagus (Lliver) 6X, Magnesium hydroxydatum (Magnesium hydroxide) 6X, Prunus (Blackthorn) 6X, Aurum met. (Metallic gold) 10X, Meteoric iron 12X
Inactive Ingredients: Water, Salt
Prepared using rhythmical processes
Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com Lot: Rev
Hel com D Amp
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