Agaricus muscarius
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2023-07-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:21:55
Label at a glance#
ProductAgaricus muscarius
Active ingredientAMANITA MUSCARIA FRUITING BODY
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Agaricus muscarius 15C
(**contains 0.443 mg of the active ingredient per pellet)
INDICATIONS & USAGE SECTION
Itching from exposure to cold*
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If pregnant or breast-feeding ask a health professional before use
SPL UNCLASSIFIED SECTION
Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
INACTIVE INGREDIENT SECTION
lactose, sucrose
DOSAGE & ADMINISTRATION SECTION
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
OTC - QUESTIONS SECTION
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-0117-41 | 2023-07-31 | C162847 | 48780-1 | f386c649-db5a-0266-e053-dadaa90a7c1a | Agaricus muscarius 15C |
| 0220-0117-41 | 2023-01-30 | C162847 | 48780-1 | f386c649-db5a-0266-e053-dadaa90a7c1a | Agaricus muscarius 15C |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-0117-41 | Agaricus muscarius | 15 [hp_C] in 1 TUBE | PELLET | 15 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Agaricus muscarius
- AMANITA MUSCARIA FRUITING BODY
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-0117 | 0220-0117-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AMANITA MUSCARIA FRUITING BODY | DIF093I037 | ACTIB |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| SUCROSE | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|
| Agaricus muscarius | AMANITA MUSCARIA FRUITING BODY | Boiron | 841397f7-62c4-7b8a-e053-2a91aa0a2882 | 2023-07-28 | 0220-0117-41 0220-0117 00220011741 01914ceb-6c91-65e9-e063-6294a90a9c21 841397f7-62c4-7b8a-e053-2a91aa0a2882 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.