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Menthol cough drop by Premier Value

Medically reviewed on December 16, 2016

Dosage form: lozenge
Ingredients: MENTHOL 5.8mg
Labeler: Premier Value
NDC Code: 68016-034

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

Menthol 5.8mg

Purpose

Cough suppressant/Oral anesthetic

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 sever, 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

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

Inactive Ingredients: acesulfame potassium, blue

flakes (FD&C blue #1, glycerin, gum arabic, potassium

sorbate), eucalyptus oil, FD&C blue #1, FD&C Red #40,

hydrogenated starch hydrolysate, isomalt, N&A flavoring,

sucralose, & water. Soybean oil and corn starch used as

processing aids.

Questions? Or to report an adverse event call

1-800-245-2898 Monday-Friday, 9AM to 4PM EST

MENTHOL COUGH DROP 
sf menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-034
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
FlavorMENTHOLImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-034-2525 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/2015
Labeler - Premier Value (101668460)
Registrant - Bestco, Inc (002149136)
Establishment
NameAddressID/FEIOperations
Bestco, Inc002149136manufacture(68016-034)

 
Premier Value

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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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