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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50332-0137-4 | THERASTAT | 1 in 1 PACKET | LOZENGE | 1 | 1 | |
| 50332-0137-4 | THERASTAT | 50 in 1 BOX | LOZENGE | 50 | 1 |
Products#
Every source-derived product name is available through these pages.
- THERASTAT
- Cherry Cough Drops
- MENTHOL
- CORN SYRUP
- EUCALYPTUS OIL
- FD&C RED NO. 40
- GLYCERIN
- MEDIUM-CHAIN TRIGLYCERIDES
- SOYBEAN OIL
- SUCROSE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50332-0137 | 50332-0137-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| CORN SYRUP | 9G5L16BK6N | IACT |
| EUCALYPTUS OIL | 2R04ONI662 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| SOYBEAN OIL | 241ATL177A | IACT |
| SUCROSE | C151H8M554 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| THERASTAT | CHERRY COUGH DROPS | HART Health | 96bae19a-3337-4199-9b8c-cdf9b368178b | 2025-08-04 | Warnings | 50332-0137-4 50332-0137 50332013704 185393b3-076a-4f6c-841b-50912e97c46b 96bae19a-3337-4199-9b8c-cdf9b368178b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
