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Menthol Cough drop by Sound Body

Medically reviewed on Mar 6, 2017

Dosage form: lozenge
Ingredients: MENTHOL 5.8mg
Labeler: Sound Body
NDC Code: 50594-033

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. 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 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

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: Corn starch, corn syrup, eucalyptus oil, FD&C red no. 40, glycerin,

medium chain triglycerides, natural & artificial flavors, 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 
cherry menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-033
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
FlavorCHERRY (menthol) Imprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:50594-033-8080 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/2017
Labeler - Sound Body (017885351)
Registrant - Bestco, Inc (002149136)
Establishment
NameAddressID/FEIOperations
Bestco,Inc002149136manufacture(50594-033)

 
Sound Body

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Further information

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

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