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Menthol cough drop by Premier Value

Dosage form: lozenge
Ingredients: MENTHOL 5.4mg
Labeler: Premier Value
NDC Code: 68016-031

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 5.4mg

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, nausea, or vomiting, consult a

doctor promptly. If sore throat 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 accomapined 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 serious condition.

  • sore throat is severe, or irritation, pain or redness lasts

or worsenes

  • 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: Blue flakes (FD&C blue no.1,

glycerin, gum arabic, potassium sorbate), eucalyptus oil,

FD&C blue no. 1, FD&C red no. 40, glucose syrup,

natural flavoring, sucrose and 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 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-031
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:68016-031-4040 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/201501/01/2019
Labeler - Premier Value (101668460)
Registrant - Bestco, Inc (002149136)
Establishment
NameAddressID/FEIOperations
Bestco, Inc002149136manufacture(68016-031)

 
Premier Value

← See all Menthol cough drop brands

Medically reviewed on Oct 19, 2018

Further information

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

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