Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID c6b36350-386b-4346-bef0-a37ec11319c0
Route
ORAL
Published
Effective Date 2022-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.7 mg)
Inactive Ingredients
Citric Acid Monohydrate Corn Syrup Eucalyptus Oil Fd&c Red No. 40 Hydrogenated Soybean Lecithin Sucrose Water

Identifiers & Packaging

Pill Appearance
Shape: oval Color: pink Size: 15 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-15

Description

 Menthol 2.7mg

Purpose

Cough Suppressant / Oral anesthetic


Medication Information

Purpose

Cough Suppressant / Oral anesthetic

Description

 Menthol 2.7mg

Use
  • Cough as may occur with a cold
  • Occasional minor irritation and sore throat
Warning

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 accompanined by excessive phlegm (mucus)

stop use and ask 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 2 lozenges (one at a time) slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor

children under 5 years , ask a doctor 

Product Label

Active Ingredient

 Menthol 2.7mg

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

Citric acid, corn syrup, eucalyptus oil, FD&C red no. 40, natural & artificial flavoring, soy lecithin, sucrose and water.


Structured Label Content

Use
  • Cough as may occur with a cold
  • Occasional minor irritation and sore throat
Purpose

Cough Suppressant / Oral anesthetic

Warning

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 accompanined by excessive phlegm (mucus)

stop use and ask 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 2 lozenges (one at a time) slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor

children under 5 years , ask a doctor 

Product Label (Product label)

Active Ingredient (Active ingredient)

 Menthol 2.7mg

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

Citric acid, corn syrup, eucalyptus oil, FD&C red no. 40, natural & artificial flavoring, soy lecithin, sucrose and water.


Advanced Ingredient Data


Raw Label Data

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