Menthol Cough Drops

Menthol Cough Drops
SPL v3
SPL
SPL Set ID 857365ba-895e-4a63-e053-2991aa0a8b9f
Route
ORAL
Published
Effective Date 2019-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.8 mg)
Inactive Ingredients
Isomalt Water Stevia Rebaudiana Whole

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: blue Size: 17 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-26
Description

Active Ingredient in each drop Purposes Menthol 5.8 mg Cough Suppressant Oral anesthetic

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, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious.

Indications and Usage

Uses Temporarily relieves:

  • cough as may occur with cold or inhaled irritants
  • ocassional minor irritations and sore throat

Dosage and Administration

Directions

  • Adults and children 5 years and over: allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.
  • Children under 5 years: ask a doctor
Description

Active Ingredient in each drop Purposes Menthol 5.8 mg Cough Suppressant Oral anesthetic

Section 34088-5

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep this and all drugs out of the reach of children.

Section 50566-9

Stop use and consult 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 last 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 excessvie phlegm (mucus)

Section 51727-6

Isomalt, stevia, water

Section 51945-4

Section 53413-1

Questions or comments call: 617-848-4560

Section 53414-9

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

Section 55105-1

Purposes

Cough suppressant/

Oral anesthetic

Section 55106-9

Active Ingredient in each drop Purposes

Menthol 5.8 mg

Cough Suppressant

Oral anesthetic

Section 60561-8

Other information

  • 6 calories per drop
  • May be useful for diabetics on the advise of a doctor
  • Excessive consumption may cause laxative effect

Structured Label Content

Indications and Usage (34067-9)

Uses Temporarily relieves:

  • cough as may occur with cold or inhaled irritants
  • ocassional minor irritations and sore throat

Dosage and Administration (34068-7)

Directions

  • Adults and children 5 years and over: allow 1 drop to dissolve slowly in mouth. May be repeated every two 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, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious.

Section 34088-5 (34088-5)

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.

Section 50566-9 (50566-9)

Stop use and consult 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 last 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 excessvie phlegm (mucus)

Section 51727-6 (51727-6)

Isomalt, stevia, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments call: 617-848-4560

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Cough suppressant/

Oral anesthetic

Section 55106-9 (55106-9)

Active Ingredient in each drop Purposes

Menthol 5.8 mg

Cough Suppressant

Oral anesthetic

Section 60561-8 (60561-8)

Other information

  • 6 calories per drop
  • May be useful for diabetics on the advise of a doctor
  • Excessive consumption may cause laxative effect

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:41.558608 · Updated: 2026-03-14T23:03:53.608631