Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 16f6d531-9298-4172-8d08-ecd87d6add76
Route
ORAL
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (9 mg)
Inactive Ingredients
Sucrose Corn Syrup Eucalyptol Lecithin, Soybean Beta Carotene Apis Mellifera

Identifiers & Packaging

Pill Appearance
Imprint: F Shape: oval Color: yellow Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Menthol 9mg

Purpose

Cough Suppressant / Oral anesthetic


Medication Information

Purpose

Cough Suppressant / Oral anesthetic

Description

Menthol 9mg

Use

Temporarily relieves:

  • cough as may occur with a cold 
  • occasional minor irritation and sore throat
Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor Promptly. Do not use more than 2 days unless directed by a doctor.

Ask a doctor before use if you have :

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanined by excessive phlegm (mucus)

stop use and ask doctor if 

  • cough persists for more than 1 week , tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

Directions
  • do not take more than directed 
  • adults and children 5 years and over : dissolve 1 drop slowly in the mouth. Repeate every 2 hours as needed.
  • children under 5 years : ask a doctor
Product Label

Active Ingredient

Menthol 9mg

Other Information
  • 12 calories per drop 
  • Contains : Soy
Inactive Ingredients

Beta carotene, corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose and water.

Keep Out of Reach of Children

Questions Or Comments? 1 844 632 7898


Structured Label Content

Use

Temporarily relieves:

  • cough as may occur with a cold 
  • occasional minor irritation and sore throat
Purpose

Cough Suppressant / Oral anesthetic

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor Promptly. Do not use more than 2 days unless directed by a doctor.

Ask a doctor before use if you have :

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanined by excessive phlegm (mucus)

stop use and ask doctor if 

  • cough persists for more than 1 week , tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

Directions
  • do not take more than directed 
  • adults and children 5 years and over : dissolve 1 drop slowly in the mouth. Repeate every 2 hours as needed.
  • children under 5 years : ask a doctor
Product Label (Product label)

Active Ingredient

Menthol 9mg

Other Information (Other information)
  • 12 calories per drop 
  • Contains : Soy
Inactive Ingredients (Inactive ingredients)

Beta carotene, corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose and water.

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

Questions Or Comments? 1 844 632 7898 (Questions or Comments? 1-844-632-7898)


Advanced Ingredient Data


Raw Label Data

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