Umcka Cold Flu Berry

Manufacturer
Schwabe North America | Schwabe North America, Inc
Effective date
2024-04-19
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:02:31

Label at a glance#

ProductUmcka Cold Flu Berry
Active ingredientPELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECAC
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

PELARGONIUM SIDOIDES 1X

ACONITUM NAPELLUS 4X

EUCALYPTUS GLOBULUS 2X

BRYONIA 4X

EUPATORIUM PERFOLIATUM 6X

GELSEMIUM SEMPERVIRENS 4X

PHOSPHORUS 6X

IPECACUANHA 3X

Inactive Ingredient

INACTIVE INGREDIENT SECTION

aronia juice
citiric acid
ethyl alcohol
glycerin
lactose monohydrate
maltodextrin
natural flavors
potassium sorbate
purified water
sorbitol

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions

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

Use only with enclosed dosage cup.

Adults & children 12 years of age and older: Take 1½ teaspoon (tsp) (7.5 mL) three times daily.

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

Children under 6 years of age: consult a physician.

Purpose

OTC - PURPOSE SECTION

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

Indications & Usage

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied or followed by a high fever, headache, nausea, vomiting, or 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, or 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 immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15148_B01 Umcka Cold & Flu Berry Syrup.jpg15148_B01 Umcka Cold & Flu Berry Syrup.jpg

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DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-9148UMCKA COLD FLU BERRY (ACONITUM NAPELLUS, BRYONIA ALBA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PELARGONIUM SIDOIDES, PHOSPHORUS) SYRUP [SCHWABE NORTH AMERICA]8Legacy NDC20240517_a83f7ee1-d4c5-4df7-a8ac-2e927fc10fdf.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
53499-914853499-9148-5

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
38e433ac-5d52-4a8f-a8da-2f67b5829dcca83f7ee1-d4c5-4df7-a8ac-2e927fc10fdf2024-04-19WarningsExact identifier
spl id: 38e433ac-5d52-4a8f-a8da-2f67b5829dcc
spl set id: a83f7ee1-d4c5-4df7-a8ac-2e927fc10fdf

Reported adverse events (FAERS/openFDA)#

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