menthol cough suppressant oral anesthetic cough drops

menthol cough suppressant oral anesthetic cough drops
SPL v2
SPL
SPL Set ID 29f2acaa-2cc8-a999-e063-6294a90a15ce
Route
oral
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (5.4 mg)
Inactive Ingredients
citric acid monohydrate corn syrup eucalyptus oil fd&c blue no. 1 fd&c red no. 40 potassium citrate soybean lecithin sucralose sucrose water

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: oval Color: blue Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-06-21

Purpose

Cough suppressant/oral anesthetic

Description

Menthol 5.4 mg


Medication Information

Warnings

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

• cough accompanied by excessive phlegm (mucus)

When using this productdo 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 mouth symptoms do not improve in 7 days

• irritation, pain, or redness persists or worsens

Uses

temporarily relieves:

• cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

Purpose

Cough suppressant/oral anesthetic

Directions

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

• children under 2 years of age: ask a doctor

Other Information

• store at room temperature.

• keep away from excessive heat or sunlight

• do not use if primary bag seal has been torn or broken.

• contains: SOY

Inactive Ingredients

citric acid, corn syrup, eucalyptus oil, FD&C blue 1, FD&C red 40, menthol flavor, potassium citrate, soy lecithin, sucralose, sucrose, water.

Description

Menthol 5.4 mg

Section 42229-5

RESEALABLE BAG

COMPARE TO ACTIVE INGREDIENT OF HALLS ®

MENTHOL FLAVOR

√ SOOTHING DROPS

√ GLUTEN FREE

√ DAIRY FREE

CLOSE BAG TO MAINTAIN FRESHNESS

DISTRIBUTED BY: 

MEDICAL GROUP CARE, LLC

NAPLES, FL 34110

MADE IN CHINA

This product is not manufactured or distributed by

Intercontinental Great Brands LLC., owner of the registered trademark HALLS ®

Contains 12 calories per lozenge

[email protected]

CHOKING HAZARD:

• SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4.

• CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.

Section 50565-1

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

Purposes

Cough suppressant/oral anesthetic

Packaging

Drug Facts

Questions Or Comments?

Call +1-866-306-9136

You may also report concerns to this phone number

Monday to Friday, 9 AM -5 PM Eastern Time or visit our website at www.mgc.us

Active Ingredient (in Each Lozenge)

Menthol 5.4 mg


Structured Label Content

Warnings

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

• cough accompanied by excessive phlegm (mucus)

When using this productdo 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 mouth symptoms do not improve in 7 days

• irritation, pain, or redness persists or worsens

Uses

temporarily relieves:

• cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

Directions

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

• children under 2 years of age: ask a doctor

Other Information (Other information)

• store at room temperature.

• keep away from excessive heat or sunlight

• do not use if primary bag seal has been torn or broken.

• contains: SOY

Inactive Ingredients (Inactive ingredients)

citric acid, corn syrup, eucalyptus oil, FD&C blue 1, FD&C red 40, menthol flavor, potassium citrate, soy lecithin, sucralose, sucrose, water.

Section 42229-5 (42229-5)

RESEALABLE BAG

COMPARE TO ACTIVE INGREDIENT OF HALLS ®

MENTHOL FLAVOR

√ SOOTHING DROPS

√ GLUTEN FREE

√ DAIRY FREE

CLOSE BAG TO MAINTAIN FRESHNESS

DISTRIBUTED BY: 

MEDICAL GROUP CARE, LLC

NAPLES, FL 34110

MADE IN CHINA

This product is not manufactured or distributed by

Intercontinental Great Brands LLC., owner of the registered trademark HALLS ®

Contains 12 calories per lozenge

[email protected]

CHOKING HAZARD:

• SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4.

• CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.

Section 50565-1 (50565-1)

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

Purposes

Cough suppressant/oral anesthetic

Packaging

Drug Facts

Questions Or Comments? (Questions or comments?)

Call +1-866-306-9136

You may also report concerns to this phone number

Monday to Friday, 9 AM -5 PM Eastern Time or visit our website at www.mgc.us

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

Menthol 5.4 mg


Advanced Ingredient Data


Raw Label Data

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