SPL v2
SPL
SPL Set ID c831d3d9-b910-40e6-bfdf-defe6850614d
Route
ORAL
Published
Effective Date 2024-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (20 mg)
Inactive Ingredients
Sucrose Corn Syrup Eucalyptol Fd&c Blue No. 1 Fd&c Red No. 40 Acacia Maltodextrin Lecithin, Soybean

Identifiers & Packaging

Pill Appearance
Imprint: F Shape: oval Color: blue Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-15
Description

Menthol 20 mg

Purpose

Oral anesthetic

Medication Information

Purpose

Oral anesthetic

Description

Menthol 20 mg

Uses

Temporarily relieves occasional minor irritation and pain due to: sore throat; sore mouth

Warnings

Sore throat warning: ore 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:

  • a severe sore throat accompanied by difficult in breathing or that lasts more than 2 days 
  • a sore 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 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

Drug Facts

Product Label

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

Menthol 20 mg

Inactive Ingredients

Corn Syrup; eucalytus oil; FD&C blue no. 1; FD&C red no. 40; Gum Arabic; Maltodextrin; natural flavor; soy lecithin; sucrose and water

Keep Out of Reach of Children.

In case of overdose, get medical gelp or contact a Poison Control Center right away

Structured Label Content

Uses

Temporarily relieves occasional minor irritation and pain due to: sore throat; sore mouth

Purpose

Oral anesthetic

Warnings

Sore throat warning: ore 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:

  • a severe sore throat accompanied by difficult in breathing or that lasts more than 2 days 
  • a sore 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 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

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
Active Ingredient  (Active ingredient )

Menthol 20 mg

Inactive Ingredients (Inactive ingredients)

Corn Syrup; eucalytus oil; FD&C blue no. 1; FD&C red no. 40; Gum Arabic; Maltodextrin; natural flavor; soy lecithin; sucrose and water

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical gelp 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: 2026-02-15T12:02:51.925102 · Updated: 2026-03-14T23:13:11.905913