Umcka Allergy and Sinus

Manufacturer
Schwabe North American, Inc. | Schwabe North America, Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:28:29

Label at a glance#

ProductUmcka Allergy and Sinus
Active ingredientPELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDE
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pelargonium sidoides 1X

Hydrastis canadensis 6X

Kali muriaticum 3X

Sanguinaria canadensis 6X

Pulsatilla 6X

Silicea 6X 

Inactive Ingredient 

INACTIVE INGREDIENT SECTION

Citric Acid

Lactose Monohydrate

Magnesium Sterate

Malic Acid

Maltodextrin

Mannitol

Natural Flavors

Sodium Croscarmellose

Sorbitol

Sour Cherry Powder

Stearic acid

Xylitol

Purpose

OTC - PURPOSE SECTION

Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms: cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.

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 allergy and sinus symptoms: cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Firections

Chew or dissolve tablets in mouth. Do not swallow whole. For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults & Children 12 years of age and older: Take 1 chewable tablet 3 times daily.

Children 6-11 of age: Take 1 chewable tablet 2 times daily.

Children under 6 years of age: Consult a physician

Warnings

WARNINGS SECTION

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 physician promptly.

Ask Doctor 

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a persistant or chronic cough that lasts, is chronic such as ocurs 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, 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

12194 Umcka Allergy & Sinus_A02.jpg12194 Umcka Allergy & Sinus_A02.jpg

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DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-3194-2Umcka Allergy and Sinus10 in 1 BLISTER PACKTABLET, CHEWABLE108
53499-3194-2Umcka Allergy and Sinus2 in 1 CARTONTABLET, CHEWABLE28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-3194UMCKA ALLERGY AND SINUS (PELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDE) TABLET, CHEWABLE [SCHWABE NORTH AMERICAN, INC.]8Legacy NDC, 2 package rows20241027_da7af566-d869-40e2-b88b-7e4a5cf5c080.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-319453499-3194-2

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#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c354ea4f-92bc-4577-9611-e4b17a837ae7da7af566-d869-40e2-b88b-7e4a5cf5c0802024-10-25WarningsExact identifier
spl id: c354ea4f-92bc-4577-9611-e4b17a837ae7
spl set id: da7af566-d869-40e2-b88b-7e4a5cf5c080

Reported adverse events (FAERS/openFDA)#

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