LEGEND COUGH LOZENGE- menthol lozenge 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals

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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LEGEND

Active Ingredient

Menthol

Purpose

Cough Suppressant/ Oral Anesthetic

Uses

Temporarily suppresses/relieves:

Warnings


Ask a doctor before use if you have

When using this product

Do not use more than directed, taking more may have a laxative effect

Stop use and ask a doctor if

Directions

Keep out of reach of children

Inactive Ingredients

Honey powder, Ginger extract, Licorice extract, Eucalyptol oil, Mexican Mint oil, Cinnamon oil, Mannitol, Sorbitol, Povidone K30, Xylitol, Silicone Dioxide, Magnesium stearate, Aspartame, Sucralose, Sodium benzoate, FD&C Yellow No. 5, FD&C Blue No. 1

Product Label

image description

LEGEND COUGH LOZENGE 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-842
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
Inactive Ingredients
Ingredient NameStrength
HONEY (UNII: Y9H1V576FH)  
GINGER (UNII: C5529G5JPQ)  
LICORICE (UNII: 61ZBX54883)  
EUCALYPTOL (UNII: RV6J6604TK)  
PLECTRANTHUS AMBOINICUS WHOLE (UNII: T444G60821)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
MANNITOL (UNII: 3OWL53L36A)  
Sorbitol (UNII: 506T60A25R)  
Povidone K30 (UNII: U725QWY32X)  
Xylitol (UNII: VCQ006KQ1E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Magnesium stearate (UNII: 70097M6I30)  
Aspartame (UNII: Z0H242BBR1)  
Sucralose (UNII: 96K6UQ3ZD4)  
Sodium benzoate (UNII: OJ245FE5EU)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Colorgreen (GREEN) Scoreno score
ShapeROUNDSize15mm
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13411-842-2424 in 1 BOX; Type 0: Not a Combination Product04/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/15/2020
Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)

Revised: 4/2020
Document Id: 69f6297d-0aa8-4719-a0e4-9b166aff8230
Set id: b56b8338-184b-4a65-85ab-7491b4b0c4fe
Version: 1
Effective Time: 20200415
 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals