SAMBUCUS FLUCARE

Manufacturer
Schwabe North America, Inc.
Effective date
2022-05-04
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 22:01:32

Label at a glance#

ProductSAMBUCUS FLUCARE
Active ingredientACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECAC
Label structure11 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

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

Elderberry extract

fructose

lactose monohydrate

magnesium stearate

malic acid

manitol

natural flavor

silica

sorbitol

sucrose

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

Chew or dissolve lozenges in the mouth.

Do not swallow lozenges whole.

For best results, use at the first sign of symptoms:

Adults and children 12 years of age and older: Take 1 chewable lozenge four times daily.
Children 6-11 years of age: Take 1 chewable lozenges two times daily.
Children under 6 years of age: Consult a physician.

Indications & Usage

INDICATIONS & USAGE SECTION

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

Purpose

OTC - PURPOSE SECTION

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

Warnings

WARNINGS SECTION

Sore throat warning: severe or persistent sore throat for more than 2 days of if accompanied by a high fever, headache, nausea, vomiting, or a rash may be serious.

Consult a physician promptly.

Ask doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema or is accompanied by excessive phlegm (mucus)

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 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. 

Pregnant or Breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdosage

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LGBN15799.A03-Sambucus-Alpha-CF-FluCare-30-Loz.jpgLGBN15799.A03-Sambucus-Alpha-CF-FluCare-30-Loz.jpg

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-977953499-9779-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
09d63d19-611a-4f6c-b3a9-e4b908366f2948bdfe6b-53b7-4298-b64f-3c2b12fa01e02022-05-04WarningsExact identifier
spl id: 09d63d19-611a-4f6c-b3a9-e4b908366f29
spl set id: 48bdfe6b-53b7-4298-b64f-3c2b12fa01e0

Reported adverse events (FAERS/openFDA)#

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