THERASTAT

Manufacturer
HART Health
Effective date
2025-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:05

Label at a glance#

ProductTHERASTAT
Active ingredientMENTHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each lozenge)

Menthol 5.8 mg

OTC - PURPOSE SECTION

Purpose

Cough suppressant/oral anesthetic

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves sore throat and cough occurring with a cold

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

Inactive ingredients 

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
476973menthol 5.8 MG Oral LozengePSN1
2548889Therastat 5.8 MG Oral LozengePSN1
2548889menthol 5.8 MG Oral Lozenge [Therastat]SBD1
476973menthol 5.8 MG Oral LozengeSCD1
2548889Therastat 5.8 MG Oral LozengeSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50332-0137-4THERASTAT1 in 1 PACKETLOZENGE11
50332-0137-4THERASTAT50 in 1 BOXLOZENGE501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-013750332-0137-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERASTATCHERRY COUGH DROPSHART Health96bae19a-3337-4199-9b8c-cdf9b368178b2025-08-04WarningsExact identifier
ndc (package): 50332-0137-4
ndc (product): 50332-0137
ndc11 (package): 50332013704
spl id: 185393b3-076a-4f6c-841b-50912e97c46b
spl set id: 96bae19a-3337-4199-9b8c-cdf9b368178b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.