SPL v2
SPL
SPL Set ID 2a2ead3c-b4d5-ee8f-e063-6294a90a3c39
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
Aspartame Lecithin, Soybean Isomalt Eucalyptus Oil Fd&c Blue No. 1 Fd&c Red No. 40 Water Acesulfame Potassium

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: oval Color: red Size: 21 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-31

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 or 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 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 1-800-245-2898. Monday - Friday, 9 AM to 4 PM EST

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. These may be serious.

Directions

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.

■ children under 5 years: ask a doctor.

Other Information

■ 5 calories per drop ■ contains: SOY.

Active Ingredient(s)

Menthol 5.8 mg

Inactive Ingredients

Acesulfame potassium, aspartame, eucalyptus oil, FD&C blue 1, FD&C red 40, flavors, isomalt, soy lecithin, water

Package Label Principal Display Panel

25 PC NDC: 61658-886-25


Structured Label Content

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation or 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 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 1-800-245-2898. Monday - Friday, 9 AM to 4 PM EST

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. These may be serious.

Directions

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.

■ children under 5 years: ask a doctor.

Other Information (Other information)

■ 5 calories per drop ■ contains: SOY.

Active Ingredient(s)

Menthol 5.8 mg

Inactive Ingredients (Inactive ingredients)

Acesulfame potassium, aspartame, eucalyptus oil, FD&C blue 1, FD&C red 40, flavors, isomalt, soy lecithin, water

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

25 PC NDC: 61658-886-25


Advanced Ingredient Data


Raw Label Data

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