Sambucus nigra
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2023-07-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:21:56
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Tube - Sambucus nigra 6C (**contains 0.443 mg of the active ingredient per pellet)
Box - Sambucus nigra 6C HPUS (**contains 0.443 mg of the active ingredient in each pellet)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
OTC - PURPOSE SECTION
Box - Relieves hoarseness with painful cough and nasal congestion*
INDICATIONS & USAGE SECTION
Tube - Hoarseness with painful cough and nasal congestion*
Box - temporarily relieves cold symptoms such as: painful cough, nasal congestion, hoarseness, loss of voice
OTC - DO NOT USE SECTION
Box - Do not use for persistent or chronic cough such as with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
OTC - STOP USE SECTION
Tube - Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
Box - Stop use and ask a doctor if cough lasts for more than 3 days, returns, or is accompanied by fever, rash, or persistent headache, as these could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
Tube - If pregnant or breast-feeding, ask a health professional before use.
Box - If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Tube - Keep out of reach of children.
Box - Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
SPL UNCLASSIFIED SECTION
Tube - 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.
Box - Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.
3 Tubes approx 80 pellets 16 Doses per tube Total 240 pellets
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and pour pellets under the tongue.
Adults & Children
Non-drowsy
Meltaway Pellets
Cough & Cold Relief*
*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
Tube - lactose, sucrose
Box - lactose, sucrose
DOSAGE & ADMINISTRATION SECTION
Tube - 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.
Box - Adults and children: 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
Tube - 1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073
Box - 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 |
|---|---|---|---|---|---|
| 0220-4536-41 | 2023-07-31 | C162847 | 48780-1 | f386c64a-0f2b-0266-e053-dadaa90a7c1a | Sambucus nigra 6C |
| 0220-4536-43 | 2023-07-31 | C162847 | 48780-1 | f386c64a-0f2b-0266-e053-dadaa90a7c1a | Sambucus nigra 6C |
| 0220-4536-41 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0f2b-0266-e053-dadaa90a7c1a | Sambucus nigra 6C |
| 0220-4536-43 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0f2b-0266-e053-dadaa90a7c1a | Sambucus nigra 6C |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-4536-41 | Sambucus nigra | 6 [hp_C] in 1 TUBE | PELLET | 6 | 4 | |
| 0220-4536-43 | Sambucus nigra | 3 in 1 BOX | PELLET | 3 | 4 | |
| 0220-4536-43 | Sambucus nigra | 6 [hp_C] in 1 TUBE | PELLET | 6 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Sambucus nigra
- SAMBUCUS NIGRA FLOWERING TOP
- SUCROSE
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-4536 | 0220-4536-41, 0220-4536-43 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SAMBUCUS NIGRA FLOWERING TOP | CT03BSA18U | 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 |
|---|---|---|---|---|---|---|
| Sambucus nigra | SAMBUCUS NIGRA FLOWERING TOP | Boiron | 86c041ec-0905-2e5b-e053-2a91aa0a2b4c | 2023-07-20 | 0220-4536-43 0220-4536-41 0220-4536 00220453641 00220453643 00f13bb7-e676-890c-e063-6294a90a47b1 86c041ec-0905-2e5b-e053-2a91aa0a2b4c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


