Menthol 20 Mg

Drug Facts

Composition & Product

Active Ingredients

Menthol (20 mg)

Inactive Ingredients

Water

Identifiers & Packaging

Pill Appearance

Imprint: B Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2019-04-11

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. Do not use more than 2 days or administer to children under 12 years of age.

Indications and Usage

Uses temporarily relieves:

occasional minor irritation and pain associated with sore throat and sore mouth

Dosage and Administration

DIrections

adults and children 12 years and over - dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

children 12 years and under - do not use

Description

Active ingredient (in each drop) Menthol 20 mg

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and consult doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens

Section 50567-7

Do not exceed recommended dosage.

Section 50569-3

Ask a doctor before use if you have

a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days.
a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting.

Section 51727-6

Inactive ingredients: Corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, glycerin, gum arabic, medium chain triglycerides, potassium sorbate, soybean oil, sucrose and water.

Section 51945-4

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

Oral anesthetic

Section 55106-9

Active ingredient (in each drop)

Menthol 20 mg

Section 60561-8

Other information

10 calories per drop
do not use if bag is torn or open

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

occasional minor irritation and pain associated with sore throat and sore mouth

Dosage and Administration (34068-7)

DIrections

adults and children 12 years and over - dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

children 12 years and under - do not use

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. Do not use more than 2 days or administer to children under 12 years of age.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and consult doctor if

sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens

Section 50567-7 (50567-7)

Do not exceed recommended dosage.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days.
a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting.

Section 51727-6 (51727-6)

Inactive ingredients: Corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, glycerin, gum arabic, medium chain triglycerides, potassium sorbate, soybean oil, sucrose and water.

Section 51945-4 (51945-4)

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

Oral anesthetic

Section 55106-9 (55106-9)

Active ingredient (in each drop)

Menthol 20 mg

Section 60561-8 (60561-8)

Other information

10 calories per drop
do not use if bag is torn or open

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "20", "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: occasional minor irritation and pain associated with sore throat and sore mouth", "34068-7": "DIrections adults and children 12 years and over - dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor. children 12 years and under - do not use", "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. Do not use more than 2 days or administer to children under 12 years of age.", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and consult doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens", "50567-7": "Do not exceed recommended dosage.", "50569-3": "Ask a doctor before use if you have a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days. a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting.", "51727-6": "Inactive ingredients : Corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, glycerin, gum arabic, medium chain triglycerides, potassium sorbate, soybean oil, sucrose and water.", "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 Oral anesthetic", "55106-9": "Active ingredient (in each drop) Menthol 20 mg", "60561-8": "Other information 10 calories per drop do not use if bag is torn or open"}