Sambucus Cold + Flu Relief Elderberry Syrup

Manufacturer
Schwabe North America | Schwabe North America, Inc.
Effective date
2026-03-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:37:52

Label at a glance#

ProductSambucus Cold Flu Relief Elderberry
Active ingredientPELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pelargonium sidoides 1x

Aconitum napellus 4x 

Eucalyptus globulus 2x

Sambucus nigra 3x

Bryonia 4x 

Eupatorium perfoliatum 6x 

Gelsemium sempervirens 4x 

Phosphorus 6x

Ipecacuanha 3x 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid

Elderberry Extract

Ethyl Alcohol 

Glycerin

Lactose Monohydrate

Maltodextrin

Natural Flavor

Purified Water

Rowanberry Extract

Sorbitol

Indications & Usage

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, cough, headache, hoarseness, body aches, sore throat, sneezing/runny nose, nasal congestion.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Shake well before each use.

Use only with enclosed dosage cup.

Adults & children 13 years of age and older: take 1½ teaspoons (tsp) (7.5 mL) three times daily.

Children 6 to 12 years of age: take 1 teaspoon (tsp) (5mL) three times daily.

Children under 6 years of age: consult a doctor.

Purpose

OTC - PURPOSE 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, cough, headache, hoarseness, body aches, sore throat, sneezing/runny nose, nasal congestion.

Warnings

WARNINGS SECTION

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

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more then 7 days or occurs with rash or persistent headache. 

These could be signs of a serious condition.

Pregnancy or Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

Overdose

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LH15136_C01_Sambucus_ColdFlu_4oz_LBL_FNLLH15136_C01_Sambucus_ColdFlu_4oz_LBL_FNL

LHBN15136_C01_Sambucus_ColdFlu_4oz_CTN_FNLLHBN15136_C01_Sambucus_ColdFlu_4oz_CTN_FNL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130033674151365GTIN-13: 0033674151365
EAN-13: 0033674151365
GTIN-12: 033674151365
UPC-A: 033674151365
GTIN storage (14 digits): 00033674151365
LHBN15136_C01_Sambucus_ColdFlu_4oz_CTN_FNL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1513-4Sambucus Cold Flu Relief Elderberry1 in 1 BOXSYRUP13
53499-1513-4Sambucus Cold Flu Relief Elderberry120 mL in 1 BOTTLESYRUP1203

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-151353499-1513-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-10-22monthly-update2026-06-03 17:37:46
12024-11-20full-release2026-06-01 02:29:00

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 ElderberrySAMBUCUS COLD FLU RELIEF ELDERBERRYSchwabe North Americadbcb3c3f-10a2-4e48-9fd9-bd6590c7239d2026-03-05WarningsExact identifier
ndc (package): 53499-1513-4
ndc (product): 53499-1513
ndc11 (package): 53499151304
spl id: 099c2af7-7ae5-4784-961a-df79fd185f74
spl set id: dbcb3c3f-10a2-4e48-9fd9-bd6590c7239d

Reported adverse events (FAERS/openFDA)#

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