Indications and uses
To relieve the symptoms of headache.
To relieve the symptoms of headache.
Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.
To relieve the symptoms of headache.
Keep this and all medicines out of reach of children.
Indications:
If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.
Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.
Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.Sucrose/Lactose
Enter section text here
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68428-163-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0057-f424-e053-dadaa90a57ce | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68428-163-01 | Spigelia Anthelmia Kit Refill | 750 in 1 VIAL, GLASS | PELLET | 750 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SPIGELIA ANTHELMIA | ACTIVE INGREDIENT | WYT05213GE | 1 | |
| SPIGELIA ANTHELMIA | ACTIVE MOIETY | WYT05213GE | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68428-163 | 68428-163-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SPIGELIA ANTHELMIA | WYT05213GE | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| LACTOSE | J2B2A4N98G | IACT |
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 |
|---|---|---|---|---|---|---|
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 620 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 193.8 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED PELLETS / ORAL | 135.2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SUPPOSITORY / VAGINAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, DELAYED RELEASE / ORAL | 231.84 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAVENOUS | 203.5 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / RESPIRATORY (INHALATION) | 90 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, EXTENDED RELEASE / ORAL | 400 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / BUCCAL | 296.7 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / SUBLINGUAL | 352 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SOLUTION / RECTAL | 8 %w/v | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAMUSCULAR | 203.5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CREAM / VAGINAL | 3 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | OINTMENT / TOPICAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SOLUTION / ORAL | 1682 mg/15ml | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, DELAYED RELEASE / ORAL | 160 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, EFFERVESCENT / ORAL | 96.5 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CONCENTRATE / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / RESPIRATORY (INHALATION) | 44.4 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 133 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, COATED / ORAL | 332.05 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 133 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / VAGINAL | 430 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / RECTAL | 20 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | FILM, EXTENDED RELEASE / TRANSDERMAL | 675 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg |
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 |
|---|---|---|---|---|---|---|
| 32f46255-e72c-4e90-9635-5b720bd0384d | 902b04f2-5151-4d4b-b4ec-760b51102fd4 | 2011-01-20 | Warnings | 32f46255-e72c-4e90-9635-5b720bd0384d 902b04f2-5151-4d4b-b4ec-760b51102fd4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.