Betula Spiraea
- Manufacturer
- Uriel Pharmacy Inc.
- Effective date
- 2018-05-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:10:10
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 cort. decoct. (Silver birch, bark dried) 3X, Betula (Silver birch leaves) 3X, Spiraea (Meadowsweet) 3X, Mandragora (Mandrake) 4X, Galena (Lead glance) 7X, Formica (Red wood ant) 10X, Arnica 17X, Equisetum (Common horsetail) 17X
INACTIVE INGREDIENT SECTION
Inactive Ingredient: Organic sucrose
OTC - PURPOSE SECTION
Use: Temporary relief of sore muscles.
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
www.urielpharmacy.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48951-2069-2 | Betula Spiraea | 1350 in 1 BOTTLE, GLASS | PELLET | 1350 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48951-2069 | BETULA SPIRAEA PELLET [URIEL PHARMACY INC.] | 3 | Legacy NDC, 1 package rows | 20180601_d6dca60f-7122-4888-a663-8a1b926fd871.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 | |
| EQUISETUM ARVENSE TOP | ACTIVE INGREDIENT | 1DP6Y6B65Z | 1 | |
| FILIPENDULA ULMARIA ROOT | ACTIVE INGREDIENT | 997724QNDS | 1 | |
| FORMICA RUFA | ACTIVE INGREDIENT | 55H0W83JO5 | 1 | |
| LEAD SULFIDE | ACTIVE INGREDIENT | 2425D15SYM | 1 | |
| MANDRAGORA OFFICINARUM ROOT | ACTIVE INGREDIENT | I2XCB174VB | 1 | |
| ARNICA MONTANA | ACTIVE MOIETY | O80TY208ZW | 1 | |
| BETULA PUBESCENS BARK | ACTIVE MOIETY | 3R504894L9 | 1 | |
| BETULA PUBESCENS LEAF | ACTIVE MOIETY | 84SOH0O3OO | 1 | |
| EQUISETUM ARVENSE TOP | ACTIVE MOIETY | 1DP6Y6B65Z | 1 | |
| FILIPENDULA ULMARIA ROOT | ACTIVE MOIETY | 997724QNDS | 1 | |
| FORMICA RUFA | ACTIVE MOIETY | 55H0W83JO5 | 1 | |
| LEAD | ACTIVE MOIETY | 2P299V784P | 1 | |
| MANDRAGORA OFFICINARUM ROOT | ACTIVE MOIETY | I2XCB174VB | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Betula Spiraea
- SUCROSE
- BETULA PUBESCENS BARK
- BETULA PUBESCENS LEAF
- FILIPENDULA ULMARIA ROOT
- MANDRAGORA OFFICINARUM ROOT
- LEAD SULFIDE
- LEAD
- FORMICA RUFA
- ARNICA MONTANA
- EQUISETUM ARVENSE TOP
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48951-2069 | 48951-2069-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| BETULA PUBESCENS BARK | 3R504894L9 | ACTIB |
| BETULA PUBESCENS LEAF | 84SOH0O3OO | ACTIB |
| FILIPENDULA ULMARIA ROOT | 997724QNDS | ACTIB |
| MANDRAGORA OFFICINARUM ROOT | I2XCB174VB | ACTIB |
| LEAD SULFIDE | 2425D15SYM | ACTIB |
| FORMICA RUFA | 55H0W83JO5 | ACTIB |
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| EQUISETUM ARVENSE TOP | 1DP6Y6B65Z | 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 | LOZENGE / BUCCAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg |
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 |
|---|---|---|---|---|---|---|
| 6d86921f-ad04-31a5-e053-2a91aa0a6a25 | d6dca60f-7122-4888-a663-8a1b926fd871 | 2018-05-31 | Warnings | 6d86921f-ad04-31a5-e053-2a91aa0a6a25 d6dca60f-7122-4888-a663-8a1b926fd871 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
