8f8a9474-f388-4ede-85f2-86222b15ee58

SPL v3
SPL
SPL Set ID 8f8a9474-f388-4ede-85f2-86222b15ee58
Route
oral
Published
Effective Date 2023-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (7.5 mg)
Inactive Ingredients
sucrose corn syrup eucalyptol lecithin, soybean apis mellifera beta carotene

Identifiers & Packaging

Pill Appearance
Shape: oval Color: yellow Size: 20 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-07-21

Purpose

Cough suppressant/Oral anesthetic

Description

Menthol 7.5 mg


Medication Information

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.

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

Cough suppressant/Oral anesthetic

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 

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

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

Description

Menthol 7.5 mg

Drug Facts

Product Label

Active Ingredient (in Each Drop)

Menthol 7.5 mg


Structured Label Content

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.

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

Cough suppressant/Oral anesthetic

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 

Other Information (Other information)
  • 11 calories per drop
  • do not use if bags is torn or open
  • Contains: Soy
Inactive Ingredients (Inactive ingredients)

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

Drug Facts

Product Label (Product label)

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

Menthol 7.5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)