ADVANCED CHERRY FLAVORED 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 7.6mg

Cough suppressant / Oral anesthetic

Uses: temporarily relieves • cough as may occur with a cold • occaional 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 symptoms 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 over: 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.

artificial cherry flavor, corn syrup, eucalyptus oil, FD& C red #40, sucrose

CHERRY COUGH DROPS 100ct CARTONCHERRY COUGH DROPS 100ct CARTON

ADVANCED CHERRY FLAVORED COUGH DROPS 
cough drops lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
CORN SYRUP (UNII: 9G5L16BK6N)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Colorred (BRIGHT RED) Scoreno score
ShapeOVALSize23mm
FlavorCHERRYImprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67060-120-74100 in 1 CARTON04/02/2019
1NDC:67060-120-011 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/02/2019
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-120)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaloz Manufacturing, Inc.067101998manufacture(67060-120)

Revised: 8/2019
Document Id: c6190c25-48f1-4e54-83eb-4d91731b58ee
Set id: 3fba2169-3645-4efb-87ee-15370fa01aab
Version: 2
Effective Time: 20190806
 
ADVANCED FIRST AID, INC.