Cough Drops
- Manufacturer
- Topco Associates LLC | Boston Nutraceutical Science SL | Boston Nutraceutical Production SL
- Effective date
- 2024-10-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:23:50
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient 5.8 mg
Cough Suppressant
Oral anesthetic
OTC - PURPOSE SECTION
Uses temporarily relieves:
- cough as may occur with a cold
- ocassional minor irritation and sore throat
INDICATIONS & USAGE SECTION
Uses temporarily relieves:
- cough as may occur with a cold
- ocassional minor irritation and sore throat
WARNINGS SECTION
Warnings
Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- a severe throat accompanied by difficulty in breathing or that last more than 2 days
- a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
OTC - STOP USE SECTION
Stop use and consult a doctor if
- sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
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 this and all drugs out of the reach of children.
OVERDOSAGE SECTION
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
- Children under 12 years and under do not use
OTHER SAFETY INFORMATION
- Store in a cool and dry place
- 10 calories per drop
INACTIVE INGREDIENT SECTION
citric acid, black currant, black carrot, flavors, glucose syrup, sucrose
OTC - QUESTIONS SECTION
Questions? or to report and adverse event call: 1-800-423-0139
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-016-01 | Cough Drops | 80 in 1 BAG | PASTILLE | 80 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Cough Drops
- Menthol
- CORN SYRUP
- SUCROSE
- CITRIC ACID MONOHYDRATE
- BLACK CURRANT
- BLACK CARROT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76162-016 | 76162-016-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CORN SYRUP | 9G5L16BK6N | IACT |
| SUCROSE | C151H8M554 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| BLACK CURRANT | 9755T40D11 | IACT |
| BLACK CARROT | 27793ZFD2L | 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 |
|---|---|---|---|---|---|---|
| Cough Drops | MENTHOL | Topco Associates LLC | eff1a70f-fa71-52b2-e053-2995a90a038c | 2024-10-07 | Warnings | 76162-016-01 76162-016 76162001601 23e6fb6c-0b9d-3900-e063-6394a90a5fe6 eff1a70f-fa71-52b2-e053-2995a90a038c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

