Umcka FastActives Berry

Manufacturer
Schwabe North America, Inc
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:28:21

Label at a glance#

ProductUmcka FastActives Berry
Active ingredientPELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECAC
Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredient

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 Ingredients

INACTIVE INGREDIENT SECTION

CITRIC ACID

LACTOSE MONOHYDRATE
MALIC ACID
MALTODEXTRIN
NATURAL FLAVORS
SILICA
XYLITOL

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions

Tear packet open, pour contents into mouth and swallow.  For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults & children 13 years of age and older: take contents of 1 packet 3 times daily.
Children 6-12 years of age: take contents of 1 packet 2 times daily.
Children under 6 years of age: consult a doctor.

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/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat. 

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/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat.

Warnings

WARNINGS SECTION

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or following 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 emphysemsa, 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 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 Posion Control Center immediately. 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LGBN15349.A02 Umcka Cold & Flu Berry Fastactives 10 ct.jpgLGBN15349.A02 Umcka Cold & Flu Berry Fastactives 10 ct.jpg

Add image transcription here...

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-9349-0Umcka FastActives Berry10 in 1 CARTONPOWDER109
53499-9349-0Umcka FastActives Berry912 mg in 1 PACKETPOWDER9129

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-9349UMCKA FASTACTIVES BERRY (PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUS) POWDER [SCHWABE NORTH AMERICA, INC]9Current NDC, Legacy NDC, 2 package rows20241025_149941fb-9b5f-42f2-bf0c-e5980f7daad6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-9349-0EA - Each53499-9349a801c212-4643-4a61-8f61-f5a2f4ab34ed12025-09-12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-934953499-9349-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Umcka FastActives BerryPELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUSSchwabe North America, Inc149941fb-9b5f-42f2-bf0c-e5980f7daad62024-10-23WarningsExact identifier
ndc (package): 53499-9349-0
ndc (product): 53499-9349
ndc11 (package): 53499934900
spl id: ce73b91f-d303-4b7a-98eb-31ca9bca585d
spl set id: 149941fb-9b5f-42f2-bf0c-e5980f7daad6

Reported adverse events (FAERS/openFDA)#

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