c831d3d9-b910-40e6-bfdf-defe6850614d

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
Purpose

Oral anesthetic

Description

Menthol 20 mg

Medication Information

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.

Uses

Temporarily 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

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

Description

Menthol 20 mg

Drug Facts

Product Label

Active Ingredient 

Menthol 20 mg

Keep Out of Reach of Children.

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

Structured Label Content

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.

Uses

Temporarily 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)

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

Drug Facts

Product Label (Product label)

Active Ingredient  (Active ingredient )

Menthol 20 mg

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