Menthol 5.8 Mg

Drug Facts

Composition & Product

Active Ingredients

Menthol (5.8 mg)

Inactive Ingredients

Water

Identifiers & Packaging

Pill Appearance

Imprint: B Shape: oval Color: red Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-03-10

Medication Information

Warnings and Precautions

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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Indications and Usage

Uses temporarily relieves:

cough as may occur with a cold

occasional minor irritation and sore throat

Dosage and Administration

Directions

adults and children 5 years and over - allow 1 drop to dissolve slowly in mouth. Repeat every 2 hours as necessary or as directed by a doctor.

children under 5 years - ask a doctor

How Supplied

Product: 50090-2960

NDC: 50090-2960-0 25 LOZENGE in a BAG

Description

Active ingredient (in each drop) Menthol 5.8 mg

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask doctor if

cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

sore throat is severe, or irritation, pain or redness lasts or worsens

sore mouth does not improve in 7 days

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 51727-6

Inactive ingredients: acesulfame potassium, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, flavoring, hydrogenated starch hydrolysate, isomalt, sucralose and water. Soybean oil and corn starch used as processing aids.

Section 53413-1

Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Cough suppressant/Oral anesthetic

Section 55106-9

Active ingredient (in each drop)

Menthol 5.8 mg

Menthol

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

cough as may occur with a cold

occasional minor irritation and sore throat

Dosage and Administration (34068-7)

Directions

adults and children 5 years and over - allow 1 drop to dissolve slowly in mouth. Repeat every 2 hours as necessary or as directed by a doctor.

children under 5 years - ask a doctor

Warnings and Precautions (34071-1)

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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask doctor if

cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

sore throat is severe, or irritation, pain or redness lasts or worsens

sore mouth does not improve in 7 days

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 51727-6 (51727-6)

Inactive ingredients: acesulfame potassium, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, flavoring, hydrogenated starch hydrolysate, isomalt, sucralose and water. Soybean oil and corn starch used as processing aids.

Section 53413-1 (53413-1)

Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Cough suppressant/Oral anesthetic

Section 55106-9 (55106-9)

Active ingredient (in each drop)

Menthol 5.8 mg

Menthol (menthol)

How Supplied (HOW SUPPLIED)

Product: 50090-2960

NDC: 50090-2960-0 25 LOZENGE in a BAG

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "5.8", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat", "34068-7": "Directions adults and children 5 years and over - allow 1 drop to dissolve slowly in mouth. Repeat every 2 hours as necessary or as directed by a doctor. children under 5 years - ask a doctor", "34071-1": "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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore throat is severe, or irritation, pain or redness lasts or worsens sore mouth does not improve in 7 days", "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)", "51727-6": "Inactive ingredients: acesulfame potassium, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, flavoring, hydrogenated starch hydrolysate, isomalt, sucralose and water. Soybean oil and corn starch used as processing aids.", "53413-1": "Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Cough suppressant/Oral anesthetic", "55106-9": "Active ingredient (in each drop) Menthol 5.8 mg", "HOW SUPPLIED": "Product: 50090-2960 NDC: 50090-2960-0 25 LOZENGE in a BAG"}