Cold Relief Kids Cherry

Manufacturer
Schwabe North America, Inc | Schwabe North America, Inc. | Thermo-Pak Company, Inc.
Effective date
2025-04-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:33:29

Label at a glance#

ProductCold Relief Kids Cherry
Active ingredientPELARGONIUM SIDOIDES ROOT
Label structure9 sections

Dosage and administration

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. Shortens duration a...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pelargonium sidoides 1X

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid

Magnesium Stearate

Malic Acid

Maltodextrin

Mannitol

Natural Flavor

Sodium Croscarmellose

Sorbitol

Stearic Acid

Xylitol

Dosage and 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.

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 a 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 you are 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 reach of children.

Overdose

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LHBN15522_01_ColdRelief_Umcka_Kids_Sams_30ct_FNL.jpgLHBN15522_01_ColdRelief_Umcka_Kids_Sams_30ct_FNL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5522-3Cold Relief Kids Cherry3 in 1 CARTONTABLET, CHEWABLE33
53499-5522-3Cold Relief Kids Cherry10 in 1 BLISTER PACKTABLET, CHEWABLE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5522COLD RELIEF KIDS CHERRY (PELARGONIUM SIDOIDES) TABLET, CHEWABLE [SCHWABE NORTH AMERICA, INC]3Current NDC, 2 package rows20250430_18168f3e-b214-494c-bacf-960247d09c49.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-552253499-5522-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 Kids CherryPELARGONIUM SIDOIDESSchwabe North America, Inc18168f3e-b214-494c-bacf-960247d09c492025-04-29WarningsExact identifier
ndc (package): 53499-5522-3
ndc (product): 53499-5522
ndc11 (package): 53499552203
spl id: 393748bc-de23-4580-9a85-ea008bebef2f
spl set id: 18168f3e-b214-494c-bacf-960247d09c49

Reported adverse events (FAERS/openFDA)#

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