SPL v4
SPL
SPL Set ID 0ea61a4c-690a-4349-9952-cc17fb1f0671
Route
ORAL
Published
Effective Date 2023-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (20 mg)
Inactive Ingredients
Sucrose Corn Syrup Eucalyptol Lecithin, Soybean Apis Mellifera Beta Carotene

Identifiers & Packaging

Pill Appearance
Shape: oval Color: yellow Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-07

Description

Menthol 20 mg

Purpose

Oral anesthetic


Medication Information

Purpose

Oral anesthetic

Description

Menthol 20 mg

Uses
  • asitemporarily relieves occasional minor irritation and pain due to
  • sore throat
  • sore mouth
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. 

Warnings

 Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

Ask a doctor before use if you have:

  • severe sore throat accompanied by difficult in breathing or that lasts more than 2 days.
  • sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting 

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days, or irritation, pain or redness lasts or worsens.

If pregnant or breast-feeding

ask a health professional before use.

Directions
 adults and children 12 years and over   dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
 children under 12 years   do not use 

Drug Facts

Product Label

Other Information
  • 11 calories per drop
  • do not use if bags is torn or open
  • Contains: Soy
Inactive Ingredients

Beta Carotene, corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose and water

Active Ingredient (in Each Drop)

Menthol 20 mg


Structured Label Content

Uses
  • asitemporarily relieves occasional minor irritation and pain due to
  • sore throat
  • sore mouth
Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. 

Purpose

Oral anesthetic

Warnings

 Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

Ask a doctor before use if you have:

  • severe sore throat accompanied by difficult in breathing or that lasts more than 2 days.
  • sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting 

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days, or irritation, pain or redness lasts or worsens.

If pregnant or breast-feeding

ask a health professional before use.

Directions
 adults and children 12 years and over   dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
 children under 12 years   do not use 

Drug Facts

Product Label (Product label)

Other Information (Other information)
  • 11 calories per drop
  • do not use if bags is torn or open
  • Contains: Soy
Inactive Ingredients (Inactive ingredients)

Beta Carotene, corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose and water

Active Ingredient (in Each Drop) (Active ingredient (in each drop))

Menthol 20 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)