Drug Facts

Composition & Product

Active Ingredients

Menthol (5 mg)

Inactive Ingredients

Ammonium Glycyrrhizate Carnauba Wax Coconut Oil Palm Kernel Oil Acacia Maltitol Sorbitol

Identifiers & Packaging

Pill Appearance

Shape: round Color: yellow Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-04-01

Medication Information

Purpose

Cough Suppressant, Oral Anesthetic

Description

Menthol 5mg

Uses

•for the temporary relief of minor sore throat

•for the temporary relief of coughs due to a cold

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. These symptoms may be serious.

Directions

•adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed.

•children under 5 years: ask a doctor

Product Label

Active Ingredient

Menthol 5mg

Other Information

• 3.1 calories per drop

Inactive Ingredients

•Ammonium glycrrhizate, carnauba wax, coconut and or palm kernel oil, flavoring, gum arabic, maltitol, sorbitol

When Using This Product

•do 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. These could be signs of a serious condition.

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

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)

Structured Label Content

Uses

•for the temporary relief of minor sore throat

•for the temporary relief of coughs due to a cold

Purpose

Cough Suppressant, Oral Anesthetic

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. These symptoms may be serious.

Directions

•adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed.

•children under 5 years: ask a doctor

Product Label

Active Ingredient

Menthol 5mg

Other Information

• 3.1 calories per drop

Inactive Ingredients

•Ammonium glycrrhizate, carnauba wax, coconut and or palm kernel oil, flavoring, gum arabic, maltitol, sorbitol

When Using This Product (When using this product)

•do not exceed recommended dosage

Stop Use and Ask A Doctor If (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. These could be signs of a serious condition.

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

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "AMMONIUM GLYCYRRHIZATE", "unii": "3VRD35U26C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PALM KERNEL OIL", "unii": "B0S90M0233", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTITOL", "unii": "D65DG142WK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "•for the temporary relief of minor sore throat •for the temporary relief of coughs due to a cold", "Purpose": "Cough Suppressant, Oral Anesthetic", "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. These symptoms may be serious.", "Directions": "•adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed. •children under 5 years: ask a doctor", "Active Ingredient": "Menthol 5mg", "Other Information": "• 3.1 calories per drop", "Inactive Ingredients": "•Ammonium glycrrhizate, carnauba wax, coconut and or palm kernel oil, flavoring, gum arabic, maltitol, sorbitol", "When using this product": "•do 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. These could be signs of a serious condition. •sore mouth does not improve in 7 days or irritation, pain or redness persists or worsens", "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)"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information