SPL v3
SPL
SPL Set ID 13c7d3b1-12ac-4931-877c-728d3d89942c
Route
ORAL
Published
Effective Date 2023-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (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
Shape: oval Color: blue Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-14

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

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

Corn Syrup, eucalyptus 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.

Active Ingredient (in Each Drop)

Menthol 20 mg


Structured Label Content

Uses

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

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:

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

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)

Corn Syrup, eucalyptus 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.)

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

Menthol 20 mg


Advanced Ingredient Data


Raw Label Data

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