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Sugar Free Menthol cough drop by DeMoulas

Dosage form: lozenge
Ingredients: MENTHOL 5.8mg
Labeler: DeMoulas
NDC Code: 53942-083

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 mouth 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 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

  • 6 calories per drop
  • Excess consumption may cause a laxative effect.

Inactive ingredients: Acesulfame potassium, blue flakes (FD&C blue no. 1, glycerin, gum

arabic, potassium sorbate), corn starch*, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40,

hydrogenated starch hydrolysate, isomalt, medium chain triglycerides*, N&A flavoring, soybean oil*,

sucralose 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

SUGAR FREE MENTHOL COUGH DROP 
sugar free menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-083
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.8 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
Colorblue (Light blue with flakes) Scorescore with uneven pieces
ShapeOVALSize16mm
FlavorMENTHOL (sugar free) Imprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:53942-083-2525 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(53942-083)

 
DeMoulas

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Medically reviewed on Feb 17, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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