ADVANCED HONEY LEMON COUGH DROPS- cough drops lozenge 
ADVANCED FIRST AID, INC.

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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Active Ingredient (in each lozenge) - Menthol 8.6mg

Cough suppressant / Oral Anesthetic

Uses: temporarily relieves • cough as may occur with a cold • occasional minor irritation and sore throat

Warnings:

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 smptoms may be serious.

Ask a doctor before use if you have: • persistent or chronic cough such as ocurs with smoking, asthma, or emphysema

• cough accompanied by excessive phlegm (mucus)

Stop use and consult a 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 babyask a health professional before use. 

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions:

• Adults and children 5 years and older: Allow lozenge to dissolve slowly in mouth; may be repeated every hour as necessary or as directed by a doctor.

Children under 5 years: Consult a doctor.

corn syrup, eucalyptus oil, D&C Yellow #10, FD& C Yellow #6, honey, lemon oil, sucrose

HONEY LEMON COUGH DROPS 100ct CARTONHONEY LEMON COUGH DROPS 100ct CARTON

ADVANCED HONEY LEMON COUGH DROPS 
cough drops lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.6 
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
CORN SYRUP (UNII: 9G5L16BK6N)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HONEY (UNII: Y9H1V576FH)  
LEMON OIL (UNII: I9GRO824LL)  
Product Characteristics
Coloryellow (BRIGHT YELLOW) Scoreno score
ShapeOVALSize23mm
FlavorMENTHOLImprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67060-121-74100 in 1 CARTON08/07/2019
1NDC:67060-121-011 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/07/2019
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-121)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaloz Manufacturing, Inc.067101998manufacture(67060-121)

Revised: 8/2019
Document Id: c5a88d98-b8fb-4a84-b6ad-3f39f142b23f
Set id: 2e83f15b-fa5e-4e5c-b43c-abab308205a2
Version: 1
Effective Time: 20190807
 
ADVANCED FIRST AID, INC.