Sambucol Cold and Flu Relief

Manufacturer
PharmaCare US, Inc. | Apotheca Company
Effective date
2024-05-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:27:01

Label at a glance#

ProductSambucol Cold and Flu Relief
Active ingredientBRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, SAMBUCUS NIGRA FLOWERING TOP, SULFUR, ZINC GLUCONATE
Label structure9 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.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 12 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in Each Tablet): Bryonia 6X,* Gelsemium Sempervirens 6X, 12X, 30X,* Sambucus Nigra 3X, 6X,* Sulphur 12X,* Zincum Gluconicum 2X, 6X.*

*Indicates the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States.

PURPOSE:

OTC - PURPOSE SECTION

Bryonia - Muscle ache, headache, dry throat, cough, Gelsemium Sempervirens - Sneezing, Sambucus Nigra - Nasal congestion, coughing, Sulphur - Nasal congestion and pressure, headache, Zincum Gluconicum - Fatigue, nausea, minor sore throat

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.**

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

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. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician. 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.

If pregnant or breast feeding, ask a health professional before using.

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

• Do not use if blister seal is broken.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 12 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.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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

QUESTIONS:

OTC - QUESTIONS SECTION

Manufactured Exclusively for 

PharmaCare US, Inc.

San Diego, CA 92108

SambucolUSA.com

or call 1-888-871-9098

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52053-0004-1

Sambucol

BLACK ELDERBERRY

COLD & FLU RELIEF
FAST TEMPORARY RELIEF FROM:
√ NASAL CONGESTION √ SORE THROAT
√ FEVER + CHILLS √ HEADACHE

√ RUNNY NOSE √ COUGH

60 TABLETS

HOMEOPATHIC

Sambucol COLD & FLU RELIEFSambucol COLD & FLU RELIEF

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52053-0004-1Sambucol Cold and Flu Relief4 in 1 CARTONTABLET43
52053-0004-2Sambucol Cold and Flu Relief4500 mg in 1 BLISTER PACKTABLET45003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52053-0004SAMBUCOL COLD AND FLU RELIEF (BRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUM) TABLET [PHARMACARE US, INC.]3Current NDC, Legacy NDC, 2 package rows20240526_7dace656-ee97-4931-869f-8c8022757abb.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
52053-000452053-0004-2, 52053-0004-1

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 · 1 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.7dace656-ee97-4931-869f-8c8022757abb2024-05-24WarningsExact identifier
ndc (package): 52053-0004-1
ndc (package): 52053-0004-2
ndc (product): 52053-0004
ndc11 (package): 52053000401
ndc11 (package): 52053000402
spl id: fc0aa1b5-3fea-406c-b8e3-151531f1c0b8
spl set id: 7dace656-ee97-4931-869f-8c8022757abb

Reported adverse events (FAERS/openFDA)#

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