Menthol Therastat by HART Health MENTHOL THERASTAT

Menthol Therastat by

Drug Labeling and Warnings

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

Drug Details [pdf]

MENTHOL THERASTAT- menthol lozenge 
HART Health

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MENTHOL THERASTAT

Active Ingredient (in each lozenge):

Menthol 5.4 mg

Purpose:

Cough Suppressant

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 accompnaied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor right away.

Ask a doctor before use if you have

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

Stop use and ask a doctor if cough lasts for more than 7 days, tends to recur or is accompanied by

• fever
• rash
• headache
• swelling
• nausea
• vomiting

These may 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 older:

• 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

Inactive Ingredients: Blue Flakes (FD&C Blue #1, Glycerin, Gum Arabic, Potassium Sorbate), Eucalyptus Oil, FD&C Red #40, Glucose Syrup, Natural Flavoring, Sucrose and Water. Soybean Oil and Corn Starch used as procession aids.

MENTHOL THERASTAT 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.4 mg

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	23mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0113-4	50 in 1 BOX, UNIT-DOSE	09/14/2006
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0113-7	125 in 1 BOX, UNIT-DOSE	09/14/2006
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 Drug	M	09/14/2006	12/31/2023

Labeler - HART Health (069560969)

Revised: 1/2024

Document Id: e7f03607-f795-4038-8806-e8816a90d55a

34390-5

Set id: 260987b0-891b-43ee-a0a0-1656c6bda93b

Version: 5

Effective Time: 20240124