Allergy and Sinus Relief

Manufacturer
Schwabe North American, Inc. | Schwabe North America, Inc. | Thermo-Pak Company, Inc.
Effective date
2025-08-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:34:54

Label at a glance#

ProductAllergy and Sinus Relief
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 Stearate

Malic Acid

Maltodextrin

Mannitol

Natural Flavor

Sodium Croscarmellose

Sorbitol

Sour Cherry Powder

Stearic acid

Xylitol

Purpose

OTC - PURPOSE SECTION

Temporarily relieves allergy and sinus symptoms.

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

Indications & Usage

INDICATIONS & USAGE SECTION

Temporarily relieves allergy and sinus symptoms.

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

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions

Chew or dissolve tablets in the mouth. Do not swallow whole. For best results, use at the 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 chewable tablet three times daily.

Children 6-12 years of age: Take 1 chewable tablet two times daily.

Children under 6 years of age: Consult a doctor.

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

LHBN12194_A02_Umcka_AllergySinus_Cherry_20chewtabs_FNL.jpgLHBN12194_A02_Umcka_AllergySinus_Cherry_20chewtabs_FNL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-4194-2Allergy and Sinus Relief10 in 1 BLISTER PACKTABLET, CHEWABLE102
53499-4194-2Allergy and Sinus Relief2 in 1 CARTONTABLET, CHEWABLE22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-4194-2EA - Each53499-419486936b3d-6434-4572-86f1-bf1a2e5424c712025-09-12

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
53499-419453499-4194-2

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#

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
Allergy and Sinus ReliefPELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDESchwabe North American, Inc.c90cc6f5-14ec-41a3-a20a-4e8018bb02fb2025-08-25WarningsExact identifier
ndc (package): 53499-4194-2
ndc (product): 53499-4194
ndc11 (package): 53499419402
spl id: 229f5cd4-f462-475f-819c-68883e543b16
spl set id: c90cc6f5-14ec-41a3-a20a-4e8018bb02fb

Reported adverse events (FAERS/openFDA)#

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