SPL v2
SPL
SPL Set ID 9f324ca1-0e2a-47e3-997e-2aaa68a85751
Route
ORAL
Published
Effective Date 2024-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (5.8 mg)
Inactive Ingredients
Corn Syrup Eucalyptol Lecithin, Soybean Fd&c Red No. 40 Sucrose

Identifiers & Packaging

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

Description

Menthol 5.8 mg

Purpose

Cough suppressant/Oral anesthetic


Medication Information

Purpose

Cough suppressant/Oral anesthetic

Description

Menthol 5.8 mg

Uses
  • temporarily relieves:
  • cough as may occur with a cold
  • occasional minor irritation and sore throat
Warnings

Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have:

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

Stop use and ask a doctor if

  • cough persists for more than 7 days, 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

If pregnant or breast-feeding

ask a health professional before use.

Directions
 adults and children 5 years and over   dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
 children under 5 years   ask a doctor 

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 red no.40, natural & artificial flavors, soy lecithin, sucrose and water.

Keep Out of Reach of Children.

Active Ingredient (in Each Drop)

Menthol 5.8 mg


Structured Label Content

Uses
  • temporarily relieves:
  • cough as may occur with a cold
  • occasional minor irritation and sore throat
Purpose

Cough suppressant/Oral anesthetic

Warnings

Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have:

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

Stop use and ask a doctor if

  • cough persists for more than 7 days, 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

If pregnant or breast-feeding

ask a health professional before use.

Directions
 adults and children 5 years and over   dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
 children under 5 years   ask a doctor 

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 red no.40, natural & artificial flavors, 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 5.8 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)