Lobelia inflata
- Manufacturer
- Boiron | Boiron Inc.
- Effective date
- 2023-11-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:24:04
Label at a glance#
ProductLobelia inflata
Active ingredientLOBELIA INFLATA
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Lobelia inflata 30X
(**contains 0.443 mg of the active ingredient per pellet)
INDICATIONS & USAGE SECTION
Nausea from tobacco withdrawal*
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
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
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 |
|---|---|---|---|---|---|
| 0220-3147-41 | 2023-11-13 | C162847 | 48780-1 | f386c649-ddc2-0266-e053-dadaa90a7c1a | Lobelia inflata 30X |
| 0220-3147-41 | 2023-01-30 | C162847 | 48780-1 | f386c649-ddc2-0266-e053-dadaa90a7c1a | Lobelia inflata 30X |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-3147-41 | Lobelia inflata | 80 in 1 TUBE | PELLET | 80 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Lobelia inflata
- SUCROSE
- LACTOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-3147 | 0220-3147-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| LOBELIA INFLATA | 9PP1T3TC5U | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Lobelia inflata | LOBELIA INFLATA | Boiron | f6813c80-7be9-11e6-81e1-424c58303031 | 2023-11-13 | 0220-3147-41 0220-3147 00220314741 0a0e60e6-7beb-acb9-e063-6394a90acb2f f6813c80-7be9-11e6-81e1-424c58303031 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.