Menthol 4.8 Mg

Drug Facts

Composition & Product

Active Ingredients

Menthol (4.8 mg)

Inactive Ingredients

Sucrose

Identifiers & Packaging

Pill Appearance

Imprint: B Shape: oval Color: brown Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2015-06-05

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 or inhaled irritants

minor sore throat

Dosage and Administration

Directions

adults and children 6 years and over - allow 2 drops to dissolve slowly in mouth one at a time. May be repeated every 2 hours as necessary or as directed by a doctor.

children under 6 years - ask a doctor

Description

Active ingredient (in each drop) Menthol 4.8 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: Caramel (color), corn starch, glucose syrup, glycerin, herbal extract blend (Elder Flower, Horehound, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), medium chain triglycerides, natural flavors, soybean oil, sucrose and water.

Section 51945-4

Section 53413-1

Questions? Or to report an adverse event call 1-800-245-2898. Monday through 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 4.8 mg

Section 60561-8

Other information

17 calories per drop

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

cough as may occur with a cold or inhaled irritants

minor sore throat

Dosage and Administration (34068-7)

Directions

adults and children 6 years and over - allow 2 drops to dissolve slowly in mouth one at a time. May be repeated every 2 hours as necessary or as directed by a doctor.

children under 6 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: Caramel (color), corn starch, glucose syrup, glycerin, herbal extract blend (Elder Flower, Horehound, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), medium chain triglycerides, natural flavors, 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 through 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 4.8 mg

Section 60561-8 (60561-8)

Other information

17 calories per drop

Advanced Ingredient Data

[{"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "4.8", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves: cough as may occur with a cold or inhaled irritants minor sore throat", "34068-7": "Directions adults and children 6 years and over - allow 2 drops to dissolve slowly in mouth one at a time. May be repeated every 2 hours as necessary or as directed by a doctor. children under 6 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: Caramel (color), corn starch, glucose syrup, glycerin, herbal extract blend (Elder Flower, Horehound, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), medium chain triglycerides, natural flavors, soybean oil, sucrose and water.", "53413-1": "Questions? Or to report an adverse event call 1-800-245-2898 . Monday through 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 4.8 mg", "60561-8": "Other information 17 calories per drop"}