0ea61a4c-690a-4349-9952-cc17fb1f0671

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

Purpose

Oral anesthetic

Description

Menthol 20 mg


Medication Information

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.

Uses
  • asitemporarily relieves occasional minor irritation and pain due to
  • sore throat
  • sore mouth
Purpose

Oral anesthetic

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 

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

Description

Menthol 20 mg

Section 50565-1

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

Drug Facts

Product Label

Active Ingredient (in Each Drop)

Menthol 20 mg


Structured Label Content

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.

Uses
  • asitemporarily relieves occasional minor irritation and pain due to
  • sore throat
  • sore mouth
Purpose

Oral anesthetic

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 

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

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. 

Drug Facts

Product Label (Product label)

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

Menthol 20 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)