Menthol 5.8 Mg

Menthol 5.8 Mg
SPL v2
SPL
SPL Set ID 3c052e93-55a5-16ce-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2014-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

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
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-06-09
Description

Active ingredient (in each drop) Menthol 5.8mg

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 dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

children under 5 years ask a doctor

Description

Active ingredient (in each drop) Menthol 5.8mg

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:

  • perisistent or chronic cough such as occurs with

smoking, asthma, or emphysema

  • cough accompanied by excessive phlegm (mucus)
Section 51727-6

Inactive ingredients: Corn starch, corn syrup,

eucalyptus oil, FD&C red no 40, glycerin, medium chain

triglycerides, natual & artificial flavors, soybean oil,

sucrose and water.

Section 51945-4

Section 53413-1

Question? Call (888) 309-9030.

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 5.8mg

Section 60561-8

Other Information 10 calories per drop

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 dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed 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:

  • perisistent or chronic cough such as occurs with

smoking, asthma, or emphysema

  • cough accompanied by excessive phlegm (mucus)
Section 51727-6 (51727-6)

Inactive ingredients: Corn starch, corn syrup,

eucalyptus oil, FD&C red no 40, glycerin, medium chain

triglycerides, natual & artificial flavors, soybean oil,

sucrose and water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question? Call (888) 309-9030.

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 5.8mg

Section 60561-8 (60561-8)

Other Information 10 calories per drop

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:39.911863 · Updated: 2026-03-14T22:55:18.422436