Cold Relief Alcohol Free Cherry Syrup

Manufacturer
Schwabe North America, Inc | ProSolutions, Inc.
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:50:52

Label at a glance#

ProductCold Relief Alcohol Free Cherry Syrup
Active ingredientPELARGONIUM SIDOIDES ROOT
Label structure4 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

PELARGONIUM SIDOIDES 1X

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ARONIA JUICE

CITRIC ACID

ETHYL ALCOHOL 

FRUCTOSE

GLYCERIN

MALTODEXTRIN

NATURAL FLAVOR

POTASSIUM SORBATE

PURIFIED WATER

Dosage & Administration:

DOSAGE & ADMINISTRATION SECTION

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

Shake well before each use.

Use only with enclosed dosage cup.

Adults and children 13 years of age and older: Take 1½ teaspoon (tsp) (7.5mL) three times daily.
Children 6-12 years of age: Take 1 teaspoon (5mL) three times daily.
Children 1-5 years of age: Take ½ teaspoon (2.5 mL) three times daily.

Indications and Usage Section

INDICATIONS & USAGE SECTION

Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial irritations: congestion, cough, hoarseness, sore throat. 

Purpose

OTC - PURPOSE SECTION

Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial irritations: congestion, cough, hoarseness, sore throat.

Warnings

WARNINGS SECTION

Sore throat warning: If sore throat is severe, persistes 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.

Individuals with allergies to plants of the Geraniaceae family should use this product with caution. 

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

LGBN14463_C01_ColdRelief_Syrup_CTN_4oz.jpgLGBN14463_C01_ColdRelief_Syrup_CTN_4oz.jpg

Add image transcription here...

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-4463COLD RELIEF ALCOHOL FREE CHERRY SYRUP (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]2Unmatched20241031_47c555da-080a-4953-abc1-587c0ea38439.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-4463-4ML - Milliliter53499-4463d0b6d6ea-4e89-48a5-9036-66c031d4758212025-08-11

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-446353499-4463-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
157308b8-6b7a-48af-a784-48beee2e74db47c555da-080a-4953-abc1-587c0ea384392024-10-29WarningsExact identifier
spl id: 157308b8-6b7a-48af-a784-48beee2e74db
spl set id: 47c555da-080a-4953-abc1-587c0ea38439

Reported adverse events (FAERS/openFDA)#

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