Umcka Elderberry Intensive Cold + Flu Syrup

Manufacturer
Schwabe North America | Schwabe North America, Inc.
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:00:00

Label at a glance#

ProductUmcka 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

Potassium Sorbate

Purified Water

Sorbitol

Indications & Usage

INDICATIONS & USAGE SECTION

Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, sneezing, stuffy/runny nose.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

For best results, use at first sign of symptoms.

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 common colds and throat/nasal/bronchial irritations: chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, sneezing, stuffy/runny nose.

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 worsen or persist for 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

LGBN15845.B02 Umcka Elderberry Syrup 4 oz (G).jpgLGBN15845.B02 Umcka Elderberry Syrup 4 oz (G).jpg

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DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-1845UMCKA ELDERBERRY SYRUP [SCHWABE NORTH AMERICA]4Legacy NDC20240627_0a4e10ba-3a9c-4dfb-8515-532f2ce1681b.zip

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
53499-184553499-1845-7

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

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
eedacaf0-a15a-48e2-8b15-2cdb391da9cc0a4e10ba-3a9c-4dfb-8515-532f2ce1681b2024-06-25WarningsExact identifier
spl id: eedacaf0-a15a-48e2-8b15-2cdb391da9cc
spl set id: 0a4e10ba-3a9c-4dfb-8515-532f2ce1681b

Reported adverse events (FAERS/openFDA)#

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