FDA.reportPublic FDA data

Sambucus Cold Flu Relief Hot Drink Lemon Flavored

Manufacturer
Universal Synergetics, Inc | Schwabe North America, Inc.
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:01

Label at a glance#

ProductSambucus Cold Flu Relief Hot Drink Lemon Flavored
Active ingredientPELARGONIUM SIDOIDES WHOLE, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECAC
Label structure8 sections

Indications and uses

temporarily relieves flu symptoms++ shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever++ chest congestion nasal congestion cough headache++ hoarseness body aches++ sneezing/runny nose++ sore throat

Dosage and administration

Dissolve contents of 1 packet in 4-6 ounes of hot water and sip while hot. May also be dissolved in 4-6 ounces of water, which may be preferable for children. for best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease  age  dose  adults & children 13 years of age and older  take 1 packet three times daily  children 6-12 years of age  take 1 packet two ti...

Label contents#

Full prescribing information#

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Pelargonium sidoides 1 X
Aconitum napellus 4X, Eucalyptus globulus 2X,
Sambucus nigra 3X
Bryonia 4X, Eupatorium perfoliatum 6X
Gelsemium sempervirens 4X, Phosphorus 6X
Ipecacuanha 3X

Purpose

OTC - PURPOSE SECTION

Shortens duration and reduces severity of upper respiratory symptoms
Pain reliever/fever reducer++
Cough suppressant++
Sneezing/runny nose/sore throat++
Nasal decongestant++

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves flu symptoms++
  • shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations:
  • chills/fever++
  • chest congestion
  • nasal congestion
  • cough
  • headache++
  • hoarseness
  • body aches++
  • sneezing/runny nose++
  • sore throat

Warnings

WARNINGS SECTION

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompained or followed by a fever, headche, rash, nausea, or vomiting, consult a doctor promptly

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that is accompained by excessive phlegm (mucus)
  • been taking any medications
  • an allergy to plants of the Geraniaceae family

Stop use and ask a doctor

OTC - STOP USE SECTION

  • new symptoms occur, symptoms get worse or last more than 7 days
  • fever worsens or lasts more than 3 days
  • cough lasts more than 7 days or occurs with rash or persistent headache

These could be sign of a serious condition.

If pregnant or brest-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, seek medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dissolve contents of 1 packet in 4-6 ounes of hot water and sip while hot. May also be dissolved in 4-6 ounces of water, which may be preferable for children.
  • for best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease
 age dose
 adults & children 13 years of age and older take 1 packet three times daily

 children 6-12 years of age

 take 1 packet two times daily
 children under 6 years of age consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • TAMPER EVIDENT.Packaged in individually sealed packets. Do not use if open or torn.
  • store at room temperature 20 25°C (68-77°F) in a dry place out of direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, elderberry extract, lactose monohydrate, maltodextrin, natural flavours, silica, xylitol

Questions?

OTC - QUESTIONS SECTION

1-800-962-8873 / naturesway.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelInner labelInner label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80228-5182-0Sambucus Cold Flu Relief Hot Drink Lemon Flavored10 in 1 CARTONPOWDER102
80228-5182-0Sambucus Cold Flu Relief Hot Drink Lemon Flavored5.3 g in 1 PACKETPOWDER5.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80228-5182SAMBUCUS COLD FLU RELIEF HOT DRINK LEMON FLAVORED (PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, SEMPERVIRENS, PHOSPHORUS) POWDER [UNIVERSAL SYNERGETICS, INC]2Current NDC, 2 package rows20250501_2ca2064a-2011-48fb-a47a-837ea3fc9bf6.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80228-518280228-5182-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EUROPEAN ELDERBERRY JUICEZ4IFJ0AK1EIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
PELARGONIUM SIDOIDES WHOLE4FY2944729ACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
EUCALYPTUS GLOBULUS LEAFS546YLW6E6ACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
PHOSPHORUS27YLU75U4WACTIB
IPECAC62I3C8233LACTIB

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 Cold Flu Relief Hot Drink Lemon FlavoredPELARGONIUM SIDOIDES, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, SEMPERVIRENS, PHOSPHORUSUniversal Synergetics, Inc2ca2064a-2011-48fb-a47a-837ea3fc9bf62025-03-04WarningsExact identifier
ndc (package): 80228-5182-0
ndc (product): 80228-5182
ndc11 (package): 80228518200
spl id: 2f89078e-1589-663a-e063-6394a90ad4c9
spl set id: 2ca2064a-2011-48fb-a47a-837ea3fc9bf6

Reported adverse events (FAERS/openFDA)#

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