Freegells Cough Drops Menthol Strawberry

Manufacturer
Riclan S.A.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:07

Label at a glance#

ProductFreegells Cough Drops Menthol Strawberry
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat

Dosage and administration

 adults and children 5 years and over  dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.  children under 5 years   ask a doctor 

Label contents#

Full prescribing information#

Active ingredient (in each drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.7 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant/ Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • cough as may occur with a cold
  • occasional minor irritation and sore throat

Warnings

WARNINGS SECTION

if sore throat is severe, persists for more than 2 days, is accompained or follwed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promtly. These symptoms may be serious. Sore throat warning:

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompained by excessive phlegm (mucus)

Stop use ask doctor if

OTC - STOP USE SECTION

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serius condition.
  • sore throat is severe, or irritation, pain o redness lasts or worsens
  • sore mouth does not improve in 7 days

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

 adults and children 5 years and over

 dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

 children under 5 years  ask a doctor 

Other information

SPL UNCLASSIFIED SECTION

  • 11 calories per drop
  • do not use if bags is torn or open
  • Contains: Soy.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

citric acid, corn syrup, eucalyptus oil, FD&C red no.40, natural & artificial flavoring, soy lecithin, sucrose and water.

Package Labeling:71165-014-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label6Label6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
433196menthol 2.7 MG Oral LozengePSN2
433196menthol 2.7 MG Oral LozengeSCD2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71165-014-00Freegells Cough Drops Menthol Strawberry30 in 1 BAGLOZENGE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71165-014FREEGELLS COUGH DROPS MENTHOL STRAWBERRY (MENTHOL) LOZENGE [RICLAN S.A.]2Current NDC, Legacy NDC, 1 package rows20231027_da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457.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
71165-01471165-014-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
Freegells Cough Drops Menthol StrawberryMENTHOLRiclan S.A.da2bbc92-7d96-4f3e-89e2-c2a9e3e4b4572023-10-26WarningsExact identifier
ndc (package): 71165-014-00
ndc (product): 71165-014
ndc11 (package): 71165001400
spl id: 08a1df47-5cbb-bce0-e063-6294a90a4023
spl set id: da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457

Reported adverse events (FAERS/openFDA)#

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