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Menthol cough drop by Demoulas

Medically reviewed on February 15, 2017

Dosage form: lozenge
Ingredients: MENTHOL 5.8mg
Labeler: Demoulas
NDC Code: 53942-081

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Active Ingredient (in each drop)

Menthol 5.8mg

Purpose

Cough suppressant/Oral anesthetic

Uses temporarily relieves:

  • cough as may occur with a cold
  • occasional minor irritation and sore throat

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)

When using this product

  • do not exceed recommended dosage

Stop use and consult 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.

Keep this and all drugs out of the reach of children. In case of accidental overdose, get

medical help or contact a Poison Control Center right away.

Directions

adults and children

5 years and over

allow 1 drop to dissolve slowly in mouth. May be repeated

every two hours as necessary or as directed by a doctor.

children under 5 years

ask a doctor

Other information

  • 10 calories per drop

Inactive ingredients: Corn starch*, eucalyptus oil, FD&C red no. 40, glucose syrup,

medium chain triglycerides*, N&A flavoring, soybean oil*, sucrose and water. *May contain

these ingredients.

Questions? Or to report an adverse event call 1-800-245-2898

Monday through Friday, 9AM to 4PM EST

MENTHOL COUGH DROP 
cherry lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-081
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.8 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
ColorredScorescore with uneven pieces
ShapeOVALSize17mm
FlavorCHERRYImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:53942-081-4040 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/26/2015
Labeler - Demoulas (007869647)
Registrant - Bestco, Inc (002149136)
Establishment
NameAddressID/FEIOperations
Bestco, Inc.002149136manufacture(53942-081)

 
Demoulas

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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