INDICATIONS & USAGE SECTION
Directions: FOR ORAL USE ONLY.
Helleborus comp. A
- Manufacturer
- Uriel Pharmacy, Inc.
- Effective date
- 2023-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:17:25
Label at a glance#
ProductHelleborus comp. A
Active ingredientFORMICA RUFA, ANTIMONY, SILVER, HELLEBORUS FOETIDUS ROOT, POTASSIUM PHOSPHATE, MONOBASIC, TIN, PHOSPHORUS, ARSENIC TRIOXIDE, JUGLANS REGIA LEAF, LEAD MONOSILICATE
Label structure8 sections
Label contents#
Full prescribing information#
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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 SECTION
Inactive Ingredients: Water, Salt, Lactose
"prepared using rhythmical processes"
OTC - PURPOSE SECTION
Use: Temporary relief of headache.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN.
WARNINGS SECTION
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains 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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Helleborus comp. A
- FORMICA RUFA
- ANTIMONY
- SILVER
- WATER
- HELLEBORUS FOETIDUS ROOT
- POTASSIUM PHOSPHATE, MONOBASIC
- PHOSPHATE ION
- TIN
- PHOSPHORUS
- SODIUM CHLORIDE
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- LACTOSE, UNSPECIFIED FORM
- JUGLANS REGIA LEAF
- LEAD MONOSILICATE
- LEAD
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48951-5134 | 48951-5134-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FORMICA RUFA | 55H0W83JO5 | ACTIB |
| ANTIMONY | 9IT35J3UV3 | ACTIB |
| SILVER | 3M4G523W1G | ACTIB |
| WATER | 059QF0KO0R | IACT |
| HELLEBORUS FOETIDUS ROOT | 332Y7EES96 | ACTIB |
| POTASSIUM PHOSPHATE, MONOBASIC | 4J9FJ0HL51 | ACTIB |
| TIN | 387GMG9FH5 | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| ARSENIC TRIOXIDE | S7V92P67HO | ACTIB |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| JUGLANS REGIA LEAF | 85HKB87105 | ACTIB |
| LEAD MONOSILICATE | TLE92T7F1J | ACTIM |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2979aab4-5ec0-425f-e063-6394a90a191d | 0ccec871-c8fb-87b6-e063-6294a90a9c0f | 2024-12-17 | Warnings | 0ccec871-c8fb-87b6-e063-6294a90a9c0f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.