HONEY LEMON COUGH DROPS- menthol lozenge 
InvaTech Pharma Solutions LLC

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.

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Drug Facts

Active Ingredient 

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

Purposes

Soothing sore throats 

Uses

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

Stop use and ask a doctor if

Keep out of reach of children

Directions

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

image description

HONEY LEMON COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57631-130
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.18 mg
Inactive Ingredients
Ingredient NameStrength
LEMON OIL (UNII: I9GRO824LL)  
HONEY (UNII: Y9H1V576FH)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
THYMOL (UNII: 3J50XA376E)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize18mm
FlavorHONEYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57631-130-71100 in 1 PACKAGE; Type 0: Not a Combination Product10/31/2017
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/FEIBusiness Operations
BAPS Swaminarayan Herbal Care, A Unit of Divine Energy921183294manufacture(57631-130) , pack(57631-130)

Revised: 12/2018
Document Id: 7df1a082-2c9c-1436-e053-2991aa0affed
Set id: e8a39c58-5137-461b-957e-b59b5bd78cc1
Version: 2
Effective Time: 20181226
 
InvaTech Pharma Solutions LLC