KOFIX CHERRY AND BLACKBERRY

Manufacturer
Global Health Solution LLC
Effective date
2022-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:31

Label at a glance#

ProductKOFIX CHERRY AND BLACKBERRY
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

for the temporary relief of  •  cough occurring with a cold  •  occasional minor irritation, pain, sore mouth, and sore throat

Dosage and administration

• adults and children 5 years and over: dissolve one lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor • children under 5 years of age: ask a doctor

Storage and handling

•  store at a cool and dry place 20ºC - 25ºC (68ºF - 77ºF) •  protect from heat, humidity and direct sunlight

Label contents#

Full prescribing information#

Active ingredient (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Menthol 8 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant / Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of  •  cough occurring with a cold  •  occasional minor irritation, pain, sore mouth, and sore throat

Warnings

WARNINGS SECTION

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by physician

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is  accompanied by excessive phlegm (mucus)

When using this product do not exceed recommended dosage

Stop use and ask a doctor if
•  cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
• sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
• sore mouth symptoms do not improve in 7 days  •  irritation, pain, or redness persists or worsens

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 5 years and over: dissolve one lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
• children under 5 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

•  store at a cool and dry place 20ºC - 25ºC (68ºF - 77ºF) •  protect from heat, humidity and direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

anethole, blackberry flavor, black currant liquid extract, carmine, cherry flavor, citric acid, clove oil, cornstarch, eucalyptus oil, gum arabic, sugar

Questions?

OTC - QUESTIONS SECTION

+1-800-550-4741, You may also report serious side effects to this phone number. Monday to Friday, 9 AM - 6 PM EST.

SPL UNCLASSIFIED SECTION

MENTHOL COUGH SUPPRESSANT/ ORAL ANESTHETIC

SORE THROAT RELIEF

CHERRY AND BLACKBERRY FLAVOR

8.2 calories per lozenge

MADE IN TURKEY

Distributed by:

Global Health Solution LLC,
8328 Kings Ridge Court,
Springfield, VA 22153

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KOFIXGLOBAL-6KOFIXGLOBAL-6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039799menthol 8 MG Oral LozengePSN2
1039799menthol 8 MG Oral LozengeSCD2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82340-002-042024-01-30C16284748780-11030e365-1d97-111a-e063-dadaa90a10e2KOFIX ​® LOZENGES
82340-002-242024-01-30C16284748780-11030e365-1d97-111a-e063-dadaa90a10e2KOFIX ​® LOZENGES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82340-002-04KOFIX CHERRY AND BLACKBERRY1 in 1 BOXLOZENGE12
82340-002-04KOFIX CHERRY AND BLACKBERRY4 in 1 BLISTER PACKLOZENGE42
82340-002-24KOFIX CHERRY AND BLACKBERRY2 in 1 BOXLOZENGE22
82340-002-24KOFIX CHERRY AND BLACKBERRY12 in 1 BLISTER PACKLOZENGE122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82340-002KOFIX CHERRY AND BLACKBERRY (MENTHOL) LOZENGE [GLOBAL HEALTH SOLUTION LLC]2Legacy NDC, 4 package rows20220109_d826d1d4-3529-416a-942a-263dd423c783.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
82340-00282340-002-24, 82340-002-04

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
bfbfeeae-a42c-402b-b169-3c2eb22f4b20d826d1d4-3529-416a-942a-263dd423c7832022-01-07WarningsExact identifier
spl id: bfbfeeae-a42c-402b-b169-3c2eb22f4b20
spl set id: d826d1d4-3529-416a-942a-263dd423c783

Reported adverse events (FAERS/openFDA)#

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