Sambucus Flu Relief

Manufacturer
Schwabe North America, Inc.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:35:43

Label at a glance#

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

Label contents#

Full prescribing information#

Active Ingredient 

OTC - ACTIVE INGREDIENT SECTION

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

Fructose

Glycerin

Lactose Monohydrate

Natural Flavor

Purified Water

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

For best results, use at first sign of symptoms and continue to use for an additonal 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 2 teaspoons (tsp) (10 mL) four times daily.

Children 6-12 years of age: Take 1 teaspoon (5 mL) four times daily.

Children under 6 years of age: Consult a doctor.

Indication & Usage

INDICATIONS & USAGE SECTION

Temporarily relieves common flu symptoms: chills/ fever, congestion, cough, headache, hoarseness, runny nose, sore throat, stuffy nose, sneezing, and body aches.

Purpose

OTC - PURPOSE SECTION

Temporarily relieves common flu symptoms: chills/ fever, congestion, cough, headache, hoarseness, runny nose, sore throat, stuffy nose, sneezing, and body aches.

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.

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 than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

Pregnancy or Breast Feeding

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

LH15803.A02-Sambucus_FluRelief_4oz_FNL.jpgLH15803.A02-Sambucus_FluRelief_4oz_FNL.jpg

LHBN15803_A02_Sambucus_FluRelief_4oz_CTN_FNL.jpgLHBN15803_A02_Sambucus_FluRelief_4oz_CTN_FNL.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130033674158036GTIN-13: 0033674158036
EAN-13: 0033674158036
GTIN-12: 033674158036
UPC-A: 033674158036
GTIN storage (14 digits): 00033674158036
LHBN15803_A02_Sambucus_FluRelief_4oz_CTN_FNL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-0803-5Sambucus Flu Relief1 in 1 BOXSYRUP14
53499-0803-5Sambucus Flu Relief120 mL in 1 BOTTLE, PLASTICSYRUP1204

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
53499-080353499-0803-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
Sambucus Flu ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOPSchwabe North America, Inc.ca7d57b0-ffae-415f-a959-b0c88ae7dd402025-12-08WarningsExact identifier
ndc (package): 53499-0803-5
ndc (product): 53499-0803
ndc11 (package): 53499080305
spl id: e952da08-d4e8-46a8-8330-99accec78283
spl set id: ca7d57b0-ffae-415f-a959-b0c88ae7dd40

Reported adverse events (FAERS/openFDA)#

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