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Menthol cough drop by Big Lots

Medically reviewed on February 9, 2017

Dosage form: lozenge
Ingredients: MENTHOL 5.4mg
Labeler: Big Lots
NDC Code: 50594-030

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.

Menthol 5.4 mg

Active Ingredient (in each drop)

Menthol 5.4mg

Purpose

Cough suppressant/Oral anesthetic

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 nasea, 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.

Keep out of reach of children

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, corn syrup, eucalyptus oil, FD&C blue no. 1, FD&C red

no. 40, glycerin, gum arabic, medium chain triglycerides, natural flavor, potassium sorbate,

soybean oil, sucrose and water.

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

Monday through Friday, 9AM to 4PM EST

MENTHOL COUGH DROP 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-030
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.4 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
Colorblue (Light blue with flakes) Scorescore with uneven pieces
ShapeOVALSize17mm
FlavorMENTHOLImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:50594-030-4040 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/05/2015
Labeler - Big Lots (017885351)
Registrant - Bestco, Inc (002149136)
Establishment
NameAddressID/FEIOperations
Bestco, Inc002149136manufacture(50594-030)

 
Big Lots

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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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