INDICATIONS & USAGE SECTION
Indications: FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness: restlessness, nervousness, exhaustion, excitability, worry or inability to fall or stay asleep.
Indications: FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness: restlessness, nervousness, exhaustion, excitability, worry or inability to fall or stay asleep.
Active Ingredients: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each ingredient at 10X, 30X, LM1 potencies.
Inactive Ingredients:
Citric acid, potassium sorbate, purified water.
Directions: Initially, depress pump until primed. Hold close and spray directly into your mouth. Take 2 pump sprays twice daily, morning and evening. Additional sprays may be taken during the night as needed. For ages 12 and above.
Warnings
Other Information:
Tamper resistant for your protection. Use only if safety seal is intact.
FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness:
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57850-0001-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-efc6-f424-e053-dadaa90a57ce | FibroCane CALM |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57850-0001-1 | FibroCane CALM | 29.6 mL in 1 BOTTLE, SPRAY | LIQUID | 29.6 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57850-0001 | FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.] | 1 | Legacy NDC, 1 package rows | 20140624_dea6be68-76fd-4a72-886e-d964b8b821d8.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACONITUM NAPELLUS | ACTIVE INGREDIENT | U0NQ8555JD | 1 | |
| AESCULUS HIPPOCASTANUM FLOWER | ACTIVE INGREDIENT | KK0Z92II8M | 1 | |
| ARABICA COFFEE BEAN | ACTIVE INGREDIENT | 3SW678MX72 | 1 | |
| ARSENIC TRIOXIDE | ACTIVE INGREDIENT | S7V92P67HO | 1 | |
| ATROPA BELLADONNA | ACTIVE INGREDIENT | WQZ3G9PF0H | 1 | |
| AVENA SATIVA FLOWERING TOP | ACTIVE INGREDIENT | MA9CQJ3F7F | 1 | |
| CAMPHOR (NATURAL) | ACTIVE INGREDIENT | N20HL7Q941 | 1 | |
| CINCHONA OFFICINALIS BARK | ACTIVE INGREDIENT | S003A158SB | 1 | |
| CYPRIPEDIUM PARVIFOLUM ROOT | ACTIVE INGREDIENT | 21Y9GZ1LZA | 1 | |
| HYOSCYAMUS NIGER | ACTIVE INGREDIENT | 4WRK2153H3 | 1 | |
| PASSIFLORA INCARNATA FLOWERING TOP | ACTIVE INGREDIENT | CLF5YFS11O | 1 | |
| PULSATILLA VULGARIS | ACTIVE INGREDIENT | I76KB35JEV | 1 | |
| STRYCHNOS IGNATII SEED | ACTIVE INGREDIENT | 1NM3M2487K | 1 | |
| VALERIAN | ACTIVE INGREDIENT | JWF5YAW3QW | 1 | |
| ACONITUM NAPELLUS | ACTIVE MOIETY | U0NQ8555JD | 1 | |
| AESCULUS HIPPOCASTANUM FLOWER | ACTIVE MOIETY | KK0Z92II8M | 1 | |
| ARABICA COFFEE BEAN | ACTIVE MOIETY | 3SW678MX72 | 1 | |
| ARSENIC CATION (3+) | ACTIVE MOIETY | C96613F5AV | 1 | |
| ATROPA BELLADONNA | ACTIVE MOIETY | WQZ3G9PF0H | 1 | |
| AVENA SATIVA FLOWERING TOP | ACTIVE MOIETY | MA9CQJ3F7F | 1 | |
| CAMPHOR (NATURAL) | ACTIVE MOIETY | N20HL7Q941 | 1 | |
| CINCHONA OFFICINALIS BARK | ACTIVE MOIETY | S003A158SB | 1 | |
| CYPRIPEDIUM PARVIFOLUM ROOT | ACTIVE MOIETY | 21Y9GZ1LZA | 1 | |
| HYOSCYAMUS NIGER | ACTIVE MOIETY | 4WRK2153H3 | 1 | |
| PASSIFLORA INCARNATA FLOWERING TOP | ACTIVE MOIETY | CLF5YFS11O | 1 | |
| PULSATILLA VULGARIS | ACTIVE MOIETY | I76KB35JEV | 1 | |
| STRYCHNOS IGNATII SEED | ACTIVE MOIETY | 1NM3M2487K | 1 | |
| VALERIAN | ACTIVE MOIETY | JWF5YAW3QW | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 57850-0001 | 57850-0001-1 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | OINTMENT / TOPICAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TROCHE / ORAL | 12 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 385 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / AURICULAR (OTIC) | 0.04 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CONCENTRATE / ORAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | PASTE / ORAL | 48 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, FILM COATED / ORAL | 42 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAPLEURAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EXTENDED RELEASE / ORAL | 45 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | LOTION / TOPICAL | 0.2 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING / ORAL | 83 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION/ DROPS / ORAL | 19 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INFILTRATION | 0.02 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAVENOUS | 396 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LOTION / TOPICAL | 0.85 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | ELIXIR / ORAL | 100 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 38 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / NASAL | 2.8 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRALESIONAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CONCENTRATE / ORAL | 5.3 mg/1ml | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SOLUTION/ DROPS / OPHTHALMIC | 0.47 %w/v | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SPRAY, METERED / NASAL | 0.06 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / TOPICAL | 0.01 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAVENOUS | 2068 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAMUSCULAR | 26 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SUSPENSION / ORAL | 840 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / SUBLINGUAL | 24 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / IONTOPHORESIS | 0.02 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SYRUP / ORAL | 2 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / INTRAVENOUS | 0.2 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAVENOUS | 10 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EFFERVESCENT / ORAL | 460 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / TOPICAL | 0.2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOAP / TOPICAL | 0.5 %w/w |
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 |
|---|---|---|---|---|---|---|
| 51938eb2-9193-4eba-a44c-986cb7195b35 | dea6be68-76fd-4a72-886e-d964b8b821d8 | 2014-06-24 | Warnings | 51938eb2-9193-4eba-a44c-986cb7195b35 dea6be68-76fd-4a72-886e-d964b8b821d8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.