THERASTAT- cherry cough drops lozenge

THERASTAT by

Drug Labeling and Warnings

THERASTAT 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 5.8 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

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

INACTIVE INGREDIENT

Inactive ingredients 

corn starch, corn syrup, eucalyptus oil, FD&C red no. 40, glycerin, medium chain triglycerides, natural & artificial flavors, soybean oil, sucrose, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERASTAT 
cherry cough drops lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0137
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.8 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	17mm
Flavor	CHERRY	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0137-4	50 in 1 BOX	08/04/2025
1		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 Drug	M	08/04/2025

Labeler - HART Health (069560969)