THORACOL- honey lemon cough drops lozenge 
HART Health

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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THORACOL

Active ingredient (in each lozenge)

Menthol 9 mg

Purpose

Cough suppressant/oral anesthetic

Uses

Temporarily relieves sore throat and cough occurring with a cold

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor right away

Ask a doctor before use if you have

Stop use and ask a doctor if:

These could be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

Do not take more than directed

Adults and children 12 years of age and over: 

Children under 12 years of age: ask a doctor

Other information

Inactive ingredients

beta carotene (color), corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose, water

Thoracol.jpg

THORACOL 
honey lemon cough drops lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0146
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE (UNII: 01YAE03M7J)  
CORN SYRUP (UNII: 9G5L16BK6N)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HONEY (UNII: Y9H1V576FH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize17mm
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0146-450 in 1 BOX01/09/2023
11 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0146-7125 in 1 BOX01/09/2023
21 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/09/2023
Labeler - HART Health (069560969)

Revised: 8/2023
Document Id: 91fce2fe-e6e3-4ad5-b95e-fc622624e8d5
Set id: ccbd5daf-29df-42ad-8108-98177250ec74
Version: 2
Effective Time: 20230810
 
HART Health