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
5
Source
full-release
Hydrated at
2026-06-01 02:37:50

Label at a glance#

ProductCold 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, stuffy/runny nose, nasal congestion.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

For best results, use at the 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, stuffy/runny nose, nasal congestion.

Warnings

WARNINGS SECTION

Sore throat warning: if sore throat is severe or 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

LH15845_C01_Umcka_ColdFluRelief_Syrup_LBL_4oz_FNLLH15845_C01_Umcka_ColdFluRelief_Syrup_LBL_4oz_FNL

LHBN15845_C01_Umcka_ColdFluRelief_Syrup_CTN_4oz_FNLLHBN15845_C01_Umcka_ColdFluRelief_Syrup_CTN_4oz_FNL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-2845-7Cold Flu Relief Elderberry120 mL in 1 BOTTLESYRUP1205
53499-2845-7Cold Flu Relief Elderberry1 in 1 BOXSYRUP15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-2845-7ML - Milliliter53499-28457e3fabeb-4a36-491d-bd2c-f92f9f5cea9412025-10-14

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
53499-284553499-2845-7

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
42025-09-09legacy-cache2026-10-22 05:55:41

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
Cold Flu Relief ElderberryCOLD FLU RELIEF ELDERBERRYSchwabe North America27ec0362-b762-442e-ad82-1f17fe15858e2026-03-05WarningsExact identifier
ndc (package): 53499-2845-7
ndc (product): 53499-2845
ndc11 (package): 53499284507
spl id: b1dac11c-acaf-4aec-9c13-b90cafe519c3
spl set id: 27ec0362-b762-442e-ad82-1f17fe15858e

Reported adverse events (FAERS/openFDA)#

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