SPL v4
SPL
SPL Set ID 61a23ce6-5157-4076-afa7-6a79c62fe9e0
Route
ORAL
Published
Effective Date 2023-07-07
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 2023-07-07

Description

Menthol 7.5 mg

Purpose

Cough suppressant/Oral anesthetic


Medication Information

Purpose

Cough suppressant/Oral anesthetic

Description

Menthol 7.5 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

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

Active Ingredient (in Each Drop)

Menthol 7.5 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)

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

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

Menthol 7.5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)