THORACOL
- Manufacturer
- HART Health
- Effective date
- 2024-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:41:42
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each lozenge)
Menthol 9 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
- 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 SECTION
Inactive ingredients
beta carotene (color), corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose, water
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50332-0146-4 | 2026-01-29 | C162847 | 48780-1 | 49896155-bdbb-586f-e063-e6dba90add90 | THORACOL |
| 50332-0146-7 | 2026-01-29 | C162847 | 48780-1 | 49896155-bdbb-586f-e063-e6dba90add90 | THORACOL |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50332-0146 | THORACOL (HONEY LEMON COUGH DROPS) LOZENGE [HART HEALTH] | 3 | Unmatched | 20241211_ccbd5daf-29df-42ad-8108-98177250ec74.zip |
Products#
Every source-derived product name is available through these pages.
- THORACOL
- Honey Lemon Cough Drops
- MENTHOL
- BETA CAROTENE
- CORN SYRUP
- EUCALYPTUS OIL
- HONEY
- LECITHIN, SOYBEAN
- SUCROSE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50332-0146 | 50332-0146-4, 50332-0146-7 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| BETA CAROTENE | 01YAE03M7J | IACT |
| CORN SYRUP | 9G5L16BK6N | IACT |
| EUCALYPTUS OIL | 2R04ONI662 | IACT |
| HONEY | Y9H1V576FH | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | 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 |
|---|---|---|---|---|---|---|
| d02188ff-0d58-4f4b-ae60-2e74890a4e7e | ccbd5daf-29df-42ad-8108-98177250ec74 | 2024-12-09 | Warnings | d02188ff-0d58-4f4b-ae60-2e74890a4e7e ccbd5daf-29df-42ad-8108-98177250ec74 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
