Umcka Elderberry Intensive Cold + Flu Syrup

Manufacturer
Schwabe North America | Schwabe North America, Inc.
Effective date
2020-05-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:32:55

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 structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Pelargonium sidoides 1x

Aconitum napellus 4x 

Eucalyptus globulus 2x

Sambucus nigra 3x

Bryonia 4x 

Eupatorium perfoliatum 6x 

Gelsemium sempervirens 4x 

Ipecacuanha 3x 

Phosphorus 6x

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Citric acid

Alcohol (0.45%)

Elderberry extract

Glycerin

Lactose monohydrate

Maltodextrin

Natural Raspberry flavor

Purified water

Sorbitol

INDICATIONS & USAGE SECTION

Purpose:

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, stuffy nose, sneezing/runny nose.

DOSAGE & ADMINISTRATION SECTION

Directions:

For best results, use at first sign of symptoms.

Continue to use for an additional 48 hours after symptoms cease.

Use only with enclosed dosage cup.

Adults and children 12 years of age and older: take 1 1/2 teaspoons (7.5 mL) three times daily.

Children 6 to 11 years of age: take 1 teaspoon (5mL) three times daily.

Children under 6 years of age: consult a doctor.

WARNINGS SECTION

Warnings:

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

Consult a doctor promptly.

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

Stop use and ask a doctor if: new symptoms occur, symptoms worsen or do not get better within 7 days, cough lasts more then 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Purpose:

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, stuffy nose, sneezing/runny nose.

UMCKA Elderberry Intensive Cold + Flu Syrup 4 oz. (15845)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15845 UMCKA ELDERBERRY  INTENSIVE COLD + FLU SYRUP  4oz 

15845_UMCKA_ELDERBERRY_SYRUP.A02.jpg15845_UMCKA_ELDERBERRY_SYRUP.A02.jpg

15845_UMCKA_ELDERBERRY_SYRUP.A02.jpg15845_UMCKA_ELDERBERRY_SYRUP.A02.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53499-9845-42020-05-04C16284748780-19d75b9cf-d39a-f424-e053-dadaa90a57ceUmcka Elderberry Intensive Cold + Flu Syrup
53499-9845-42020-01-31C16284748780-19d75b9cf-d39a-f424-e053-dadaa90a57ceUmcka Elderberry Intensive Cold + Flu Syrup

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-984553499-9845-4

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 · Source PDF

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
70c60514-b956-44aa-9220-f79dd020ff42e1318ee5-b030-41e4-a65b-e53f30e064792020-05-04WarningsExact identifier
spl id: 70c60514-b956-44aa-9220-f79dd020ff42
spl set id: e1318ee5-b030-41e4-a65b-e53f30e06479

Reported adverse events (FAERS/openFDA)#

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