Sambucol Cold and Flu Relief

Manufacturer
PharmaCare US, Inc. | Nutritional Laboratories International Inc | Ion Labs Inc
Effective date
2022-04-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:17:19

Label at a glance#

ProductSambucol Cold and Flu Relief
Active ingredientBRYONIA ALBA ROOT, SAMBUCUS NIGRA FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, ZINC GLUCONATE, SULFUR
Label structure8 sections

Indications and uses

Temporarily relieves cold & flu symptoms. Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and headache. Also temporarily relieves body aches associated with the flu.

Dosage and administration

For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside. Adults and children 4 years of age and older - Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.

Storage and handling

Do not use if blister seal is broken ​Active ingredients are monographed and microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Bryonia 6X

Gelsemium sempervirens 6X, 12X, 30X

Sambucus nigra 3X, 6X

Sulphur 12X

Zincum gluconicum 2X, 6X

Purpose

OTC - PURPOSE SECTION

Bryonia 6X................Muscle ache, headache, dry throat, cough

Gelsemium sempervirens 6X, 12X, 30X.......................Sneezing

Sambucus nigra 3X, 6X...................Nasal congestion, coughing

Sulphur 12X....................Nasal congestion and pressure, headache

Zincum gluconicum 2X, 6X..........................Fatigue, nausea, minor sore throat

* The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves cold & flu symptoms.
  • Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and headache.
  • Also temporarily relieves body aches associated with the flu.

Warnings

WARNINGS SECTION

Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

OTC - DO NOT USE SECTION

Do not use for children under 4 years of age.

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Symptoms worsen
  • Any new symptoms appear
  • Fever lasts for more than three days
  • Respiratory symptoms persist for more than seven days

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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside.

Adults and children 4 years of age and older - Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.

Other Information

STORAGE AND HANDLING SECTION

  • Do not use if blister seal is broken

​Active ingredients are monographed and microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Black Carrot Extract (colorant), Croscarmellose Sodium, Elderberry Flavor, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Sucrose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 52053-0001-4

Sambucol

Black Elderberry

Cold & Flu Relief

90 Count Family Pack

Take at the first sign of cold and flu symptoms

**Temporary relief from:

  • Nasal & sinus congestion
  • Runny nose
  • Sore throat
  • Coughing
  • Sneezing

90 Tablets

Homeopathic

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52053-0001-42023-07-28C16284748780-10191ceaa-6e4d-198a-e063-dbdaa90aec3eSambucol Cold and Flu Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52053-0001-4Sambucol Cold and Flu Relief6 in 1 CARTONTABLET, ORALLY DISINTEGRATING62
52053-0001-4Sambucol Cold and Flu Relief4500 mg in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING45002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52053-0001SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET, ORALLY DISINTEGRATING [PHARMACARE US, INC.]2Current NDC, Legacy NDC, 2 package rows20220413_ce66e57d-ae46-0973-e053-2a95a90a6165.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52053-000152053-0001-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sambucol Cold and Flu ReliefBRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUMPharmaCare US, Inc.4dc2088f-3f13-4e49-83e4-44c2a26d195f2024-11-04WarningsExact identifier
ndc (product): 52053-0001
dc7af5e5-755b-1b40-e053-2995a90a54e1ce66e57d-ae46-0973-e053-2a95a90a61652022-04-12WarningsExact identifier
spl id: dc7af5e5-755b-1b40-e053-2995a90a54e1
spl set id: ce66e57d-ae46-0973-e053-2a95a90a6165

Reported adverse events (FAERS/openFDA)#

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