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menthol cough drop by Sound Body

Dosage form: lozenge
Ingredients: MENTHOL 5.8mg
Labeler: Sound Body
NDC Code: 50594-032

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
Menthol 5.8mg

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 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

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: Eucalyptus oil, FD&C red

no. 40, glucose syrup, N&A 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 
cherry menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-032
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.8 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
ColorredScorescore with uneven pieces
ShapeOVALSize17mm
FlavorCHERRYImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:50594-032-4040 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/24/201302/01/2020
Labeler - Sound Body (017885351)
Registrant - Bestco, Inc. (002149136)
Establishment
NameAddressID/FEIOperations
Bestco, Inc.002149136manufacture(50594-032)

 
Sound Body

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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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