Indications & Usage
Directions: FOR ORAL USE ONLY.
Helleborus Comp. A
FDA Label NDC 48951-5136
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Uriel Pharmacy, Inc. for the product Helleborus Comp. A (NDC 48951-5136). 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 indications & usage, dosage & administration, otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.
Otc - Active Ingredient
Active Ingredients: Helleborus e pl. tota (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, Stannum met. (metallic tin) 12X, Arsenicum album (white arsenic) 17X, Plumbum Silicicum (lead silicate) 20X
Inactive Ingredient
Inactive Ingredients: Water, Salt, Lactose
"prepared using rhythmical processes"
Otc - Purpose
Use: Temporary relief of headache.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains traces of lactose. 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. Do not use if safety seal is broken or missing.
* Please review the disclaimer below.
