Kofix®

Kofix®
SPL v2
SPL
SPL Set ID d5585285-8791-4726-8fa4-ff5fd1f75688
Route
ORAL
Published
Effective Date 2022-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (9.3 mg)
Inactive Ingredients
Caramel Clove Oil Starch, Corn Eucalyptus Oil Ginger Oil Acacia Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-11-01

Description

Menthol 9.3 mg

Purpose

Cough suppressant / Oral anesthetic


Medication Information

Purpose

Cough suppressant / Oral anesthetic

Description

Menthol 9.3 mg

Uses

for the temporary relief of 

•  cough occurring with a cold 

•  occasional minor irritation, pain, sore mouth, and sore throat

Section 42229-5

MENTHOL COUGH SUPPRESSANT/ORAL ANESTHETIC

SORE THROAT RELIEF

GINGER FLAVOR

8.6 calories per lozenge

MADE IN TURKEY

Distributed by:

Global Health Solution LLC,


8328 Kings Ridge Court,

Springfield, VA 22153

Section 50565-1

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

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.

Packaging

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

Drug Facts

Questions?

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

Other Information

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

Inactive Ingredients

caramel, clove oil, cornstarch, eucalyptus oil, ginger flavor, ginger oil, gum arabic, sugar

Active Ingredient (in Each Lozenge)

Menthol 9.3 mg


Structured Label Content

Uses

for the temporary relief of 

•  cough occurring with a cold 

•  occasional minor irritation, pain, sore mouth, and sore throat

Section 42229-5 (42229-5)

MENTHOL COUGH SUPPRESSANT/ORAL ANESTHETIC

SORE THROAT RELIEF

GINGER FLAVOR

8.6 calories per lozenge

MADE IN TURKEY

Distributed by:

Global Health Solution LLC,


8328 Kings Ridge Court,

Springfield, VA 22153

Section 50565-1 (50565-1)

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

Purpose

Cough suppressant / Oral anesthetic

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.

Packaging

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

Drug Facts

Questions?

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

caramel, clove oil, cornstarch, eucalyptus oil, ginger flavor, ginger oil, gum arabic, sugar

Active Ingredient (in Each Lozenge) (Active ingredient (in each lozenge))

Menthol 9.3 mg


Advanced Ingredient Data


Raw Label Data

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