Umcka Original ColdCare Drops

Manufacturer
Schwabe North America | Schwabe North America, Inc
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:35

Label at a glance#

ProductUmcka Original ColdCare
Active ingredientPELARGONIUM SIDOIDES ROOT
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

PELARGONIUM SIDOIDES 1X

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Ethyl Alcohol

Glycerin

Maltodextrin

Purified Water

Dosage & Administation

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. 

Adults & children 13 years of age and older: take 1.5 mL three times daily by mouth.

Children 12 years of age and under: consult a physician before use.

Indications & Usage

INDICATIONS & USAGE SECTION

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.

Purpose

OTC - PURPOSE SECTION

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.

Warnings

WARNINGS SECTION

Sore throat warning: if sore throat is severe, 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 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.

Overdosage

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LGBN15790.A02-Umcka-Original-Liquid-2oz-(G+D).jpgLGBN15790.A02-Umcka-Original-Liquid-2oz-(G+D).jpg

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-6270-4Umcka Original ColdCare1 in 1 CARTONLIQUID12
53499-6270-4Umcka Original ColdCare30 mL in 1 BOTTLE, DROPPERLIQUID302
53499-6270-8Umcka Original ColdCare59.1 mL in 1 BOTTLE, DROPPERLIQUID59.12
53499-6270-8Umcka Original ColdCare1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-6270UMCKA ORIGINAL COLDCARE (PELARGONIUM SIDOIDES) LIQUID [SCHWABE NORTH AMERICA]24 package rows20241031_4b1fbd9f-9780-4274-9e02-d0ca96c19490.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-6270-4ML - Milliliter53499-6270ea4360f6-b00f-4349-9c1e-6bb944f0e3a412025-09-12
53499-6270-8ML - Milliliter53499-6270dcf1852d-6d55-4ae6-ad37-80e715b0241b12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-627053499-6270-4, 53499-6270-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
90a7c95c-54f3-430d-998a-33f578756e6c4b1fbd9f-9780-4274-9e02-d0ca96c194902024-10-29WarningsExact identifier
spl id: 90a7c95c-54f3-430d-998a-33f578756e6c
spl set id: 4b1fbd9f-9780-4274-9e02-d0ca96c19490

Reported adverse events (FAERS/openFDA)#

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