drug facts

drug facts
SPL v3
SPL
SPL Set ID dc077c36-c403-4b83-894a-e9922e928841
Route
oral
Published
Effective Date 2023-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (2.7 mg)
Inactive Ingredients
sucrose corn syrup eucalyptol lecithin, soybean fd&c red no. 40 citric acid monohydrate

Identifiers & Packaging

Pill Appearance
Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-07-14

Purpose

Cough Suppressant / Oral anesthetic

Description

 Menthol 2.7 mg


Medication Information

Purpose

Cough Suppressant / Oral anesthetic

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 

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

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

Description

 Menthol 2.7 mg

Use

Temporarily relieves:

  • 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.

Product Label

Active Ingredient

 Menthol 2.7 mg

Keep Out of Reach of Children


Structured Label Content

Purpose

Cough Suppressant / Oral anesthetic

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 

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

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

Use

Temporarily relieves:

  • 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.

Product Label (Product label)

Active Ingredient (Active ingredient)

 Menthol 2.7 mg

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


Advanced Ingredient Data


Raw Label Data

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