Menthol 5.0 Mg

Menthol 5.0 Mg
SPL v2
SPL
SPL Set ID 1ba4b2be-7242-0a23-e063-6294a90af29c
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Imprint: RD Shape: round Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-24

Description

Active ingredient (in each soft lozenge) Menthol 5 mg


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 older dissolve one soft lozenge in mouth. Repeat every 2 hours as needed or as directed by a doctor. Children under 5 years consult a doctor.

Description

Active ingredient (in each soft lozenge) Menthol 5 mg

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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: Citric acid, corn syrup, FD&C blue #1, FD&C red #40, medium chain triglycerides, natural flavor, pectin, propylene glycol, sodium citrate, sucrose, water.

Section 51945-4

Section 53413-1

Questions? 1-888-287-1915

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 soft lozenge)

Menthol 5 mg

Section 60561-8

Other information

  • 10 calories per lozenge

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 older dissolve one soft lozenge in mouth. Repeat every 2 hours as needed or as directed by a doctor. Children under 5 years consult 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 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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: Citric acid, corn syrup, FD&C blue #1, FD&C red #40, medium chain triglycerides, natural flavor, pectin, propylene glycol, sodium citrate, sucrose, water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-888-287-1915

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 soft lozenge)

Menthol 5 mg

Section 60561-8 (60561-8)

Other information

  • 10 calories per lozenge

Advanced Ingredient Data


Raw Label Data

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