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#

ProductSambucus nigra
Active ingredientSAMBUCUS NIGRA FLOWERING TOP
Label structure12 sections

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

labellabellabellabellabellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-4536-412023-07-31C16284748780-1f386c64a-0f2b-0266-e053-dadaa90a7c1aSambucus nigra 6C
0220-4536-432023-07-31C16284748780-1f386c64a-0f2b-0266-e053-dadaa90a7c1aSambucus nigra 6C
0220-4536-412023-01-30C16284748780-1f386c64a-0f2b-0266-e053-dadaa90a7c1aSambucus nigra 6C
0220-4536-432023-01-30C16284748780-1f386c64a-0f2b-0266-e053-dadaa90a7c1aSambucus nigra 6C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-4536-41Sambucus nigra6 [hp_C] in 1 TUBEPELLET64
0220-4536-43Sambucus nigra3 in 1 BOXPELLET34
0220-4536-43Sambucus nigra6 [hp_C] in 1 TUBEPELLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-4536SAMBUCUS NIGRA (SAMBUCUS NIGRA FLOWERING TOP ) PELLET [BOIRON]4Current NDC, Legacy NDC, 3 package rows20230729_86c041ec-0905-2e5b-e053-2a91aa0a2b4c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-45360220-4536-41, 0220-4536-43

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sambucus nigraSAMBUCUS NIGRA FLOWERING TOPBoiron86c041ec-0905-2e5b-e053-2a91aa0a2b4c2023-07-20Exact identifier
ndc (package): 0220-4536-43
ndc (package): 0220-4536-41
ndc (product): 0220-4536
ndc11 (package): 00220453641
ndc11 (package): 00220453643
spl id: 00f13bb7-e676-890c-e063-6294a90a47b1
spl set id: 86c041ec-0905-2e5b-e053-2a91aa0a2b4c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.