Amyl nitrosum
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2024-05-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:26:50
Label at a glance#
ProductAmyl nitrosum
Active ingredientAMYL NITRITE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Amyl nitrosum 5C HPUS
Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).
INDICATIONS & USAGE SECTION
Uses: See symptoms on front panel.
Relieves hot flash followed by cold sweats *
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
Keep out of reach of children.
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.
INACTIVE INGREDIENT SECTION
lactose, sucrose
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.
OTC - QUESTIONS SECTION
BoironUSA.com Info@boiron.com
1-800-BOIRON-1
(1-800-264-7661)
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 |
|---|---|---|---|---|---|
| 0220-0300-41 | 2023-10-18 | C162847 | 48780-1 | f386c649-9ec5-0266-e053-dadaa90a7c1a | Amyl nitrosum 5C |
| 0220-0300-41 | 2023-01-30 | C162847 | 48780-1 | f386c649-9ec5-0266-e053-dadaa90a7c1a | Amyl nitrosum 5C |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-0300-41 | Amyl nitrosum | 5 [hp_C] in 1 TUBE | PELLET | 5 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Amyl nitrosum
- AMYL NITRITE
- SUCROSE
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-0300 | 0220-0300-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AMYL NITRITE | 22T8Z09XAK | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | 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 |
|---|---|---|---|---|---|---|
| Amyl nitrosum | AMYL NITRITE | Boiron | 6a103131-036a-7173-e053-2991aa0a4e87 | 2024-05-03 | 0220-0300-41 0220-0300 00220030041 1792d543-9630-2038-e063-6294a90afc1f 6a103131-036a-7173-e053-2991aa0a4e87 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.