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Honey Lemon Cough Drops by InvaTech Pharma Solutions LLC

Medically reviewed on Oct 31, 2017

Dosage form: lozenge
Ingredients: MENTHOL 3.18mg
Labeler: InvaTech Pharma Solutions LLC
NDC Code: 57631-130

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.

Drug Facts

Active Ingredient 

Menthol (From Mentha spicata) (in each 3gm Drop of Serving Size)....................................................3.18 mg

Purposes

Soothing sore throats 

Uses
  • Natural way of calming cough and soothing sore throats

Warnings

Sore throat warnings: 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 may be serious.

Do not use for children under 6 years of age unless directed by a doctor. 

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 a doctor if
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persist or worsens

Keep out of reach of children

Directions
  • adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as if needed or as directed by a doctor
  • children under 6 years: ask a doctor
  • do not bite or chew

Other information

Protect from heat and moisture 

Inactive Ingredients

Lemon oil, honey, eucalyptus, camphor, thymol, tartrazin color q.s., flavored sugar base q.s.

OTC Principal Display Panel

Honey Lemon Cough Drops

100ct Bag

HONEY LEMON COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57631-130
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.18 mg
Inactive Ingredients
Ingredient NameStrength
LEMON OIL 
HONEY 
CAMPHOR (SYNTHETIC) 
THYMOL 
EUCALYPTUS OIL 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize18mm
FlavorHONEYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57631-130-71100 LOZENGE in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/31/2017
Labeler - InvaTech Pharma Solutions LLC (078602180)
Establishment
NameAddressID/FEIOperations
BAPS Swaminarayan Herbal Care, A Unit of Divine Energy921183294manufacture(57631-130), pack(57631-130)

 
InvaTech Pharma Solutions LLC

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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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