SPL v1
SPL
SPL Set ID 38034ad2-5eab-9caf-e063-6294a90abb8f
Route
ORAL
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.8 mg)
Inactive Ingredients
Maltitol Sucralose Lecithin, Soybean Isomalt Eucalyptus Oil Fd&c Blue No. 1 Fd&c Red No. 40 Water Acesulfame Potassium

Identifiers & Packaging

Pill Appearance
Shape: oval Color: red Size: 21 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-20

Description

Menthol 5.8 mg

Purpose

Purposes cough suppressant, oral anesthetic


Medication Information

Purpose

Purposes cough suppressant, oral anesthetic

Description

Menthol 5.8 mg

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation, pain, sore mouth, and sore throat

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens.

Section 50567-7

When using this product do not exceed recommended dosage

Section 50569-3

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

Section 53413-1

call +8009352362. You may also report concerns to this phone number. Monday - Friday, 9 AM to 5 PM EASTERN TIME

Warnings

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

Directions

■ adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed.

■ children under 2 years: ask a doctor.

Other Information

■ 5 calories per drop ■ 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.

Active Ingredient(s)

Menthol 5.8 mg

Inactive Ingredients

Acesulfame potassium, black cherry flavor, eucalyptus oil, FD&C blue 1, FD&C red 40, isomalt, maltitol, menthol flavor, soy lecithin, sucralose, water

Package Label Principal Display Panel


Structured Label Content

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation, pain, sore mouth, and sore throat

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50569-3 (50569-3)

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

Section 53413-1 (53413-1)

call +8009352362. You may also report concerns to this phone number. Monday - Friday, 9 AM to 5 PM EASTERN TIME

Purpose

Purposes cough suppressant, oral anesthetic

Warnings

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

Directions

■ adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed.

■ children under 2 years: ask a doctor.

Other Information (Other information)

■ 5 calories per drop ■ 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.

Active Ingredient(s)

Menthol 5.8 mg

Inactive Ingredients (Inactive ingredients)

Acesulfame potassium, black cherry flavor, eucalyptus oil, FD&C blue 1, FD&C red 40, isomalt, maltitol, menthol flavor, soy lecithin, sucralose, water

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)