Cold Relief Lemon

Manufacturer
Schwabe North America, Inc. | Universal Synergetics, Inc.
Effective date
2025-07-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:34:35

Label at a glance#

ProductCold Relief Lemon
Active ingredientPELARGONIUM SIDOIDES ROOT
Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pelargonium sidoides 1X

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid

Maltodextrin

Natural Flavor

Silica

Turmeric Color

Xylitol

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.

May also be dissolved in 4-6 ounces of cold water, which may be preferable for children.

For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults and children 13 years of age and older: Take 1 packet three times daily.

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

Children under 6 years of age: Consult a doctor.

Indications & Usage

INDICATIONS & USAGE SECTION

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

Pregnant 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

LHBN15146_A02_Umcka_ColdCare_LemonHotDrink_CTN_FNL.jpgLHBN15146_A02_Umcka_ColdCare_LemonHotDrink_CTN_FNL.jpg

LHPK15146_A02_Umcka_ColdCare_LemonHotDrink_PKT_FNL.jpgLHPK15146_A02_Umcka_ColdCare_LemonHotDrink_PKT_FNL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-6146-0Cold Relief Lemon5 g in 1 PACKETPOWDER53
53499-6146-0Cold Relief Lemon10 in 1 CARTONPOWDER103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-6146-0EA - Each53499-6146e7dc1bc8-ad7b-43d3-8a59-a4ce5a4a69a812025-09-12

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
53499-614653499-6146-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
Cold Relief LemonPELARGONIUM SIDOIDESSchwabe North America, Inc.f5c9b1c4-dbc6-4fa3-bc41-4ee4bf417eb52025-07-31WarningsExact identifier
ndc (package): 53499-6146-0
ndc (product): 53499-6146
ndc11 (package): 53499614600
spl id: d3410778-39cc-4789-9f7f-0d0aa5659eea
spl set id: f5c9b1c4-dbc6-4fa3-bc41-4ee4bf417eb5

Reported adverse events (FAERS/openFDA)#

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