KOFIX CHERRY AND BLACKBERRY- menthol lozenge 
Global Health Solution LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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KOFIX​® LOZENGES

Drug Facts

Active ingredient (in each lozenge)

Menthol 8 mg

Purpose

Cough suppressant / Oral anesthetic

Uses

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

Warnings

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.

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

Directions

• 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

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

Inactive ingredients

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

Questions?

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

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

KOFIXGLOBAL-6

KOFIX CHERRY AND BLACKBERRY 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82340-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM8 mg
Inactive Ingredients
Ingredient NameStrength
ANETHOLE (UNII: Q3JEK5DO4K)  
BLACK CURRANT JUICE (UNII: 9L8NK01P32)  
CARMINIC ACID (UNII: CID8Z8N95N)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CLOVE OIL (UNII: 578389D6D0)  
STARCH, CORN (UNII: O8232NY3SJ)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ACACIA (UNII: 5C5403N26O)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize19mm
FlavorCHERRY, BLACKBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82340-002-242 in 1 BOX11/01/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:82340-002-041 in 1 BOX01/06/2022
24 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2021
Labeler - Global Health Solution LLC (117922627)

Revised: 1/2022
Document Id: bfbfeeae-a42c-402b-b169-3c2eb22f4b20
Set id: d826d1d4-3529-416a-942a-263dd423c783
Version: 2
Effective Time: 20220107
 
Global Health Solution LLC