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menthol cough drop by Harmon Stores, Inc

Medically reviewed on February 23, 2017

Dosage form: lozenge
Ingredients: MENTHOL 5.4mg
Labeler: Harmon Stores, Inc
NDC Code: 63940-090

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 5.4mg

Purpose

Cough supressant/

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,

headaches, 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 besigns 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

dissolve 1 lozenge slowly in

mouth. Repeat every 2 hours

as needed 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), corn starch,

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

no. 40, medium chain triglycerides, natural flavor,

soybean oil, sugar and water.

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:63940-090
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:63940-090-3030 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/10/2015
Labeler - Harmon Stores, Inc (804085293)
Registrant - Bestco, Inc. (002149136)
Establishment
NameAddressID/FEIOperations
Bestco, Inc.002149136manufacture(63940-090)

 
Harmon Stores, Inc

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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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