Sambucus Cold Flu Relief Elderberry Chewable Tablet

Manufacturer
Schwabe North America, Inc. | Schwabe North America, Inc | Thermo-Pak Company, Inc.
Effective date
2025-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:37:13

Label at a glance#

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

Dosage and administration

Directions Chew or dissolve tablets in the mouth.   Do not swallow whole. For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. Adults and children 13 years of age and older: Take 1 chewable tablet three times daily. Children 6-12 years of age: Take 1 chewable tablet two times daily. Children under 6 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

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 Ingredient

INACTIVE INGREDIENT SECTION

Annatto Seed Extract Color

Beet Juice Color

Caramel Color

Elderberry Extract

Lactose Monohydrate

Magnesium Stearate

Malic Acid

Maltodextrin

Mannitol

Natural Flavor

Sodium Croscarmellose

Sorbitol

Stearic Acid

Xylitol

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

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

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions

Chew or dissolve tablets in the mouth.  Do not swallow whole.

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

Adults and children 13 years of age and older: Take 1 chewable tablet three times daily.

Children 6-12 years of age: Take 1 chewable tablet two times daily.

Children under 6 years of age: Consult a doctor.

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 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 you are 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

LHBN15175_01_Sambucus_ColdFluRelief_20ct_FNL.jpgLHBN15175_01_Sambucus_ColdFluRelief_20ct_FNL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5175-0Sambucus Cold Flu Relief Elderberry10 in 1 BLISTER PACKTABLET, CHEWABLE102
53499-5175-0Sambucus Cold Flu Relief Elderberry2 in 1 CARTONTABLET, CHEWABLE22

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-517553499-5175-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-12-11full-release2026-06-01 02:29:27

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 ElderberryPELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECACSchwabe North America, Inc.aaa28ba9-6abd-46da-8ffa-83178505aeee2025-10-22WarningsExact identifier
ndc (package): 53499-5175-0
ndc (product): 53499-5175
ndc11 (package): 53499517500
spl id: fefba925-a094-463f-9b76-b460200f0a07
spl set id: aaa28ba9-6abd-46da-8ffa-83178505aeee

Reported adverse events (FAERS/openFDA)#

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