THORACOL- honey lemon cough drops lozenge

THORACOL by

Drug Labeling and Warnings

THORACOL by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each lozenge)

Menthol 9 mg

PURPOSE

Purpose

Cough suppressant/oral anesthetic

INDICATIONS & USAGE

Uses

Temporarily relieves sore throat and cough occurring with a cold

WARNINGS

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 DOCTOR

Ask a doctor before use if you have

• a cough acccompanied by excessive phlegm (mucus)
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

STOP USE

Stop use and ask a doctor if:

• sore mouth does improve in 7 days
• irritation, pain or redness persists or worsens
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache

These could be signs of a serious condition

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

Do not take more than directed

Adults and children 12 years of age and over: 

• allow one lozenge to dissolve slowly in mouth
• may be repeated every 2 hours as needed or as directed by a doctor

Children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

• Contains: SOY
• 12 calories per drop
• store at 59° to 86°F (15°-30°C) in a dry place
• avoid excessive heat and humidity

INACTIVE INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THORACOL 
honey lemon cough drops lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0146
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	9 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score	no score
Shape	OVAL	Size	17mm
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0146-4	50 in 1 BOX	01/09/2023
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0146-7	125 in 1 BOX	01/09/2023
2		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/09/2023

Labeler - HART Health (069560969)