HERBOMINT 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)....................................................9.99 mg

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

Stop use and ask a doctor if

Keep out of reach of children

Directions

Other information

Protect from heat and moisture

Inactive Ingredients

Holy Basil, Liquorice, Acacia catechu, Malabar, Cardamom, Clove, eucalyptus oil, caramel color q.s sugar base q.s

PURPOSE

Natural way of calming cough and soothing sore throats

OTC Principal Display Panel

Herbomint Cough Drops

100ct

100

HERBOMINT COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57631-205
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9.99 mg
Inactive Ingredients
Ingredient NameStrength
CARDAMOM (UNII: 8BC4CUT4JL)  
CARAMEL (UNII: T9D99G2B1R)  
BASIL (UNII: 2U0KZP0FDW)  
LICORICE (UNII: 61ZBX54883)  
ACACIA CATECHU WHOLE (UNII: TJ6XA84OQF)  
MALABAR PLUM JUICE (UNII: 58D570WY62)  
CLOVE (UNII: K48IKT5321)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
RAW SUGAR (UNII: 8M707QY5GH)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize18mm
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57631-205-29100 in 1 PACKAGE; Type 0: Not a Combination Product05/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/22/2019
Labeler - InvaTech Pharma Solutions LLC (078602180)
Establishment
NameAddressID/FEIBusiness Operations
BAPS Swaminarayan Herbal Care, A Unit of Divine Energy921183294manufacture(57631-205) , pack(57631-205)

Revised: 5/2019
Document Id: 897cebe8-f1b0-0eb0-e053-2a95a90a66bb
Set id: 897cffe0-b744-8c4e-e053-2a95a90aceb2
Version: 1
Effective Time: 20190522
 
InvaTech Pharma Solutions LLC