FDA.reportPublic FDA data

Umcka Coldcare Lemon

Manufacturer
ProSolutions, Inc. | Schwabe North America, Inc.
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:39:51

Label at a glance#

ProductUmcka Coldcare Lemon
Active ingredientPELARGONIUM SIDOIDES ROOT
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients panelActive Ingredients panel

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients panelInactive Ingredients panel

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration panelDosage and Administration panel

Indications and Usage

INDICATIONS & USAGE SECTION

Indications and Usage panelIndications and Usage panel

Warnings

WARNINGS SECTION

Warnings panelWarnings panel

Ask a Doctor

OTC - ASK DOCTOR SECTION

Ask a Doctor panelAsk a Doctor panel

Stop use

OTC - STOP USE SECTION

Stop use panelStop use panel

Pregnancy or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy or Breast Feeding panelPregnancy or Breast Feeding panel

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach panelKeep out of reach panel

Over dosage

OVERDOSAGE SECTION

Over Dosage panelOver Dosage panel

Purpose

OTC - PURPOSE SECTION

Purpose panelPurpose panel

Package Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package panelPackage panel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83102-5146UMCKA COLDCARE LEMON (PELARGONIUM SIDOIDES) POWDER [PROSOLUTIONS, INC.]2Unmatched20250411_f5776f96-13fb-0570-e053-2a95a90aa12c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83102-514683102-5146-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TURMERIC856YO1Z64FIACT
XYLITOLVCQ006KQ1EIACT
PELARGONIUM SIDOIDES ROOTH6J53HEX8EACTIB

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
326cbf07-4e79-f367-e063-6294a90a17f3f5776f96-13fb-0570-e053-2a95a90aa12c2025-04-10WarningsExact identifier
spl id: 326cbf07-4e79-f367-e063-6294a90a17f3
spl set id: f5776f96-13fb-0570-e053-2a95a90aa12c

Reported adverse events (FAERS/openFDA)#

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