Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 165a8efa-2b03-4329-99fa-3233f0af7d08
Route
ORAL
Published
Effective Date 2025-11-04
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 Fd&c Blue No. 1 Fd&c Red No. 40 Acacia Maltodextrin

Identifiers & Packaging

Pill Appearance
Shape: oval Color: blue Size: 2 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01
Description

 Menthol 20 mg

Purpose

Oral anesthetic

Medication Information

Purpose

Oral anesthetic

Description

 Menthol 20 mg

Use

Temporarily relieves occasional minor irritation and pain due to:

  • sore throat
  • sore mouth
Warning

Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a 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 :

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

Stop use and ask doctor if 

  • sore mouth symptoms do not improve in 7 days or if 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.

Product Label

Active Ingredient

 Menthol 20 mg

Other Information
  • 11 calories per drop  
  • Do not use if the bag is torn or open. 
  • Contains: Soy
Inactive Ingredients

Artificial flavors, corn syrup, eucalyptus oil, FD&C Blue No. 1, FD&C Red No. 40,  Gum Arabic, Maltodextrin, Soy Lecithin, sucrose and water.

Keep Out of Reach of Children. in Case of Overdose, Get Medical Help Or Contact A Poison Control Center Right Away. 

Structured Label Content

Use

Temporarily relieves occasional minor irritation and pain due to:

  • sore throat
  • sore mouth
Purpose

Oral anesthetic

Warning

Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a 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 :

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

Stop use and ask doctor if 

  • sore mouth symptoms do not improve in 7 days or if 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.

Product Label (Product label)

Active Ingredient (Active ingredient)

 Menthol 20 mg

Other Information (Other information)
  • 11 calories per drop  
  • Do not use if the bag is torn or open. 
  • Contains: Soy
Inactive Ingredients (Inactive ingredients)

Artificial flavors, corn syrup, eucalyptus oil, FD&C Blue No. 1, FD&C Red No. 40,  Gum Arabic, Maltodextrin, Soy Lecithin, sucrose and water.

Keep Out of Reach of Children. in Case of Overdose, Get Medical Help Or Contact A Poison Control Center Right Away.  (Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. )

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:35.479762 · Updated: 2026-03-14T23:11:13.760766