Umcka ColdCare Alcohol-Free Drops

Manufacturer
Schwabe North America, Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:25

Label at a glance#

ProductUmcka ColdCare Alcohol-Free
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

citric acid

ethyl alcohol

glycerin

maltodextrin

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. 

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

Children 6-12 years of age: Take 1 mL three times daily by mouth.

Children 1-5 years of age: Take 0.5 mL three times daily by mouth.

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.

Overdose

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LGBN15791.B03 Umcka Orig 99.9 Alcoh-Free Liq 2oz.jpgLGBN15791.B03 Umcka Orig 99.9 Alcoh-Free Liq 2oz.jpg

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-6271-8Umcka ColdCare Alcohol-Free1 in 1 CARTONLIQUID12
53499-6271-8Umcka ColdCare Alcohol-Free59 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-6271UMCKA COLDCARE ALCOHOL-FREE (PELARGONIUM SIDOIDES) LIQUID [SCHWABE NORTH AMERICA, INC.]2Current NDC, 2 package rows20241027_5e290fb1-4dd6-4a7e-a1e5-41e2863bc34a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-6271-8ML - Milliliter53499-62712919f487-14dc-42e7-a66c-2a8efbf42dc212025-10-14

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-627153499-6271-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 ColdCare Alcohol-FreePELARGONIUM SIDOIDESSchwabe North America, Inc.5e290fb1-4dd6-4a7e-a1e5-41e2863bc34a2024-10-25WarningsExact identifier
ndc (package): 53499-6271-8
ndc (product): 53499-6271
ndc11 (package): 53499627108
spl id: 8a8ed8f1-8e8c-4a7f-bd76-a22d795ed288
spl set id: 5e290fb1-4dd6-4a7e-a1e5-41e2863bc34a

Reported adverse events (FAERS/openFDA)#

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