Secale Betula
- Manufacturer
- Uriel Pharmacy Inc.
- Effective date
- 2024-11-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 02:29:05
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Directions: FOR ORAL USE ONLY.
DOSAGE & ADMINISTRATION SECTION
Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: Betula e fol. (Silver birch leaves) 3X, Betula e cort. (Silver birch bark) 4X, Levisticum (Lovage) 6X, Nicotiana (Tobacco) 6X, Secale corn. (Ergot) 6X, Galena (Lead glance) 8X, Retina et chor. (Bovine retina and choroid) 8X, Arnica 12X
INACTIVE INGREDIENT SECTION
Inactive Ingredient: Organic sucrose
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 sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. 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.
OTC - QUESTIONS SECTION
Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 shopuriel.com Lot:
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 04cdd491-d111-4bc2-9549-75c575e1bd4b | Product name | 1 | 20200714 |
| 8390fb8b-6c75-416c-a9a1-70e8ed493b73 | Product name | 1 | 20200611 |
| 96a528e9-23e2-495f-81b9-ae87df2f7552 | Product name | 1 | 20191120 |
| 3df56c93-5837-4523-aac2-4b1ec48b9676 | Product name | 2 | 20160719 |
| a883b7cc-d320-41d7-92ae-c873457ae641 | Product name | 1 | 20151116 |
| bb23e78e-9e64-4037-a1c1-0e1d8762700e | Product name | 1 | 20150325 |
| ef06c001-572c-d95e-42f6-ee83da75673a | Product name | 1 | 20140508 |
| fd21f957-6863-d07b-5a35-250186878716 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48951-8175-2 | Secale Betula | 1350 in 1 BOTTLE, GLASS | PELLET | 1350 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48951-8175 | SECALE BETULA PELLET [URIEL PHARMACY INC.] | 5 | Legacy NDC, 1 package rows | 20241127_1bcd7f9f-b833-41b4-8e87-1ff7baf20108.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARNICA MONTANA | ACTIVE INGREDIENT | O80TY208ZW | 1 | |
| BETULA PUBESCENS BARK | ACTIVE INGREDIENT | 3R504894L9 | 1 | |
| BETULA PUBESCENS LEAF | ACTIVE INGREDIENT | 84SOH0O3OO | 1 | |
| BOS TAURUS EYE | ACTIVE INGREDIENT | VTW461N43P | 1 | |
| CLAVICEPS PURPUREA SCLEROTIUM | ACTIVE INGREDIENT | 01G9XEA93N | 1 | |
| LEAD SULFIDE | ACTIVE INGREDIENT | 2425D15SYM | 1 | |
| LEVISTICUM OFFICINALE ROOT | ACTIVE INGREDIENT | 46QZ19OEX8 | 1 | |
| TOBACCO LEAF | ACTIVE INGREDIENT | 6YR2608RSU | 1 | |
| ARNICA MONTANA | ACTIVE MOIETY | O80TY208ZW | 1 | |
| BETULA PUBESCENS BARK | ACTIVE MOIETY | 3R504894L9 | 1 | |
| BETULA PUBESCENS LEAF | ACTIVE MOIETY | 84SOH0O3OO | 1 | |
| BOS TAURUS EYE | ACTIVE MOIETY | VTW461N43P | 1 | |
| CLAVICEPS PURPUREA SCLEROTIUM | ACTIVE MOIETY | 01G9XEA93N | 1 | |
| FERRIC CATION | ACTIVE MOIETY | 91O4LML611 | 1 | |
| LEVISTICUM OFFICINALE ROOT | ACTIVE MOIETY | 46QZ19OEX8 | 1 | |
| TOBACCO LEAF | ACTIVE MOIETY | 6YR2608RSU | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Secale Betula
- SUCROSE
- BETULA PUBESCENS LEAF
- BETULA PUBESCENS BARK
- LEVISTICUM OFFICINALE ROOT
- TOBACCO LEAF
- CLAVICEPS PURPUREA SCLEROTIUM
- LEAD SULFIDE
- FERRIC CATION
- BOS TAURUS EYE
- ARNICA MONTANA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48951-8175 | 48951-8175-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| BETULA PUBESCENS LEAF | 84SOH0O3OO | ACTIB |
| BETULA PUBESCENS BARK | 3R504894L9 | ACTIB |
| LEVISTICUM OFFICINALE ROOT | 46QZ19OEX8 | ACTIB |
| TOBACCO LEAF | 6YR2608RSU | ACTIB |
| CLAVICEPS PURPUREA SCLEROTIUM | 01G9XEA93N | ACTIB |
| LEAD SULFIDE | 2425D15SYM | ACTIB |
| BOS TAURUS EYE | VTW461N43P | ACTIB |
| ARNICA MONTANA | O80TY208ZW | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA |
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 |
|---|---|---|---|---|---|---|
| 27c1c944-4740-3db9-e063-6394a90a5188 | 1bcd7f9f-b833-41b4-8e87-1ff7baf20108 | 2024-11-25 | Warnings | 27c1c944-4740-3db9-e063-6394a90a5188 1bcd7f9f-b833-41b4-8e87-1ff7baf20108 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
